Legalize / United Kingdom / Statutory-Instrument

The Human Medicines Regulations 2012

Type Statutory-Instrument

Publication 2012-07-19

Last updated 2026-03-31

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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(5) If the public analyst to whom a sample is submitted thinks that a proper analysis cannot be carried out for any reason, the public analyst must send it to the public analyst for some other area, who must as soon as practicable analyse the sample, or cause it to be analysed (subject to paragraph 6).

(6) A public analyst to whom a sample is submitted or sent under this regulation may demand payment in advance of the required fee, and if payment in advance is demanded may refuse to carry out the analysis until the fee is paid.

(7) A public analyst who has analysed a sample or caused it to be analysed must issue a certificate specifying the result of the analysis to the person by whom the sample was submitted under paragraph (2).

(8) Paragraphs 21 to 23 of Schedule 31 have effect in relation to a certificate issued under this regulation as they have effect in relation to a certificate issued under paragraph 19 of that Schedule.

(9) In this regulation “public analyst”—

(a) in relation to England and Wales and Scotland has the meaning given by section 27 of the Food Safety Act 1990 ; and

(b) in relation to Northern Ireland has the meaning given by Article 27(1) of the Food Safety (Northern Ireland) Order 1991 .

Findings and reports of inspections

331

(1) If the outcome of the inspection of things referred to in regulation 327(2)(g) (powers of inspection, sampling and seizure: information and documents relating to safety etc) is that the holder of a UK marketing authorisation ... or traditional herbal registration does not comply with the pharmacovigilance system as described in the pharmacovigilance system master file, or any provision of Part 11 (pharmacovigilance), the enforcement authority must—

(a) bring the deficiencies to the attention of the holder;

(b) give the holder the opportunity to submit comments; and

(c) in the case of a product authorised under a UKMA(NI) or UKMA(UK)(Category 2), inform the other EEA States, the EMA and the European Commission.

(2) Paragraph (1) is without prejudice to paragraphs (3) and (5).

(3) After every inspection carried out in accordance with regulations 325 (rights of entry) and 327 (powers of inspection, sampling and seizure) in connection with medicinal products other than registrable homoeopathic medicinal products, the enforcement authority must report on whether the activities to which the inspection relates comply with such of the provisions mentioned in paragraph (4) as apply to those activities.

(4) Those provisions are—

(a) the Good Manufacturing Practice Directive and any principles or guidelines of good manufacturing practice referred to in Article 47 of the 2001 Directive;

(b) the guidelines on good distribution practice—

(i) in the case of Great Britain, published under, or that apply by virtue of, regulation C17;

(ii) in the case of Northern Ireland, published by the European Commission in accordance with Article 84 of the 2001 Directive;

(i) Part 11 (pharmacovigilance), and

(ii) Chapter 3 (pharmacovigilance) of Title II (authorisation and supervision of medicinal products for human use) of Regulation (EC) No 726/2004.

(d) Schedule 12A; and

(e) the Implementing Regulation (as defined in regulation 177(5)).

(5) The enforcement authority must before adopting the report —

(a) communicate the content of the report to the person to whose activities the inspection relates; and

(b) give that person the opportunity to submit comments.

Restrictions on disclosure of information

332

(1) A person (“P”) must not disclose to another person, otherwise than in the performance of P's functions—

(a) any information relating to a manufacturing process or trade secret obtained by P on premises which P has entered by virtue of regulation 325 or of a warrant under regulation 326; or

(b) any information obtained by P or given to P in pursuance of these Regulations.

(2) Paragraph (1) does not apply if—

(a) P is, or is acting on behalf of, a public authority for the purposes of the Freedom of Information Act 2000 ; and

(b) the information is not held by the authority on behalf of another person.

Protection for inspectors

333

(1) An inspector is not personally liable in respect of any act done in the execution, or purported execution, of a function under these Regulations and within the scope of the inspector's employment by an enforcement authority (or, where the inspector is not employed by the authority, the scope of the inspector's authorisation), provided that the act was done in the honest belief that these Regulations required or permitted it.

(2) Where an action is brought against an inspector in respect of an act falling within paragraph (1), the enforcement authority may indemnify the inspector against any damages, costs or expenses incurred, if the authority is satisfied that the inspector honestly believed that these Regulations required or permitted the act.

(3) Paragraph (2) applies in a case where the person is not legally entitled to require an indemnity from the enforcement authority.

(4) A reference to an inspector in this regulation includes a reference to an employee of the licensing authority who accompanies an inspector pursuant to regulation 334(1).

Supplementary provisions and offences

334

(1) An inspector entering any premises by virtue of regulation 325 or of a warrant under regulation 326 may be accompanied by such persons, and take such equipment, as the inspector thinks appropriate.

(2) Where an inspector enters premises in pursuance of a warrant under regulation 326, the inspector must, if the property is unoccupied or the occupier is temporarily absent, leave the premises as effectively secured against trespass as they were before the inspector entered.

(3) It is an offence for a person—

(a) intentionally to obstruct an inspector;

(b) intentionally to fail to comply with a requirement properly made under regulation 327 by an inspector; or

(c) without reasonable cause, to fail to give an inspector any other assistance or information which the inspector may reasonably require in order to perform a function under these Regulations.

(4) A person guilty of an offence under paragraph (3) is liable on summary conviction to a fine not exceeding level 3 on the standard scale.

(5) A person who knowingly makes a false statement in giving information as mentioned in paragraph (3)(c) is guilty of an offence.

(6) A person who breaches the prohibition in regulation 332(1) (restrictions on disclosure of information) is guilty of an offence.

(7) A person who is guilty of an offence under paragraph (5) or (6) is liable—

(a) on summary conviction to a fine not exceeding the statutory maximum; or

(b) on conviction on indictment to a fine or to imprisonment for a term not exceeding two years, or to both.

(8) Nothing in this regulation is to be read as requiring a person to answer a question or to give information if doing so might incriminate that person or the spouse or civil partner of that person.

(9) In this regulation “occupier”, in relation to a ship, aircraft, or vehicle, is to be read in accordance with regulation 326(4).

PART 17 — Miscellaneous and general

Provisions relating to offences

Contravention due to fault of another person

335

(1) This regulation applies where—

(a) a contravention of a provision referred to in paragraph (6) constitutes an offence; and

(b) a person (“A”) contravenes the provision by reason of the act or omission of another person (“B”).

(2) B may be charged with and convicted of the offence, whether or not proceedings are also brought against A.

(3) If B is convicted B is liable to the same punishment as would have been imposed on A if A had been convicted of the offence.

(4) If A is charged with the offence it is a defence for A to prove on the balance of probabilities that—

(a) A exercised all due diligence to avoid contravening the provision; and

(b) the contravention was due to the act or omission of B.

(5) A may not rely on the defence in paragraph (4) unless not later than seven clear days before the date of the hearing A serves on the prosecutor a notice in writing of any information held by A which identifies, or assists in identifying, B.

(6) The provisions mentioned in paragraph (1) are—

(a) regulation 251 (compliance with standards specified in certain publications);

(b) regulations 268, 268A, 269 and 269A (offences relating to packaging and package leaflets);

(d) regulation 275 (colouring of aspirin and paracetamol products for children);

(e) any prohibition or requirement in Chapter 2 of Part 14 (advertising); and

(f) regulations 305(4) and 306(7) and (8) (notices not to publish, or to cease to publish, an advertisement.

Warranty as defence

336

(1) This regulation applies where proceedings are brought against a person (“the defendant”) for an offence under these Regulations in respect of a contravention of a provision mentioned in paragraph (3).

(2) It is a defence for the defendant to prove that—

(a) the substance or article to which the contravention relates (the “relevant substance or article”) was sold to the defendant in the United Kingdom as—

(i) a substance or article which could be lawfully sold, supplied or offered for sale or supply, or

(ii) a substance or article which could be lawfully sold, supplied or offered for sale or supply under the name or description or for the purpose under or for which it was sold;

(b) the relevant substance or article was sold with a written warranty certifying a matter specified in paragraph (a), and that if the warranty were true the alleged offence would not have been committed;

(c) at the time of the commission of the alleged offence the defendant had no reason to believe that the matter certified in the warranty was otherwise; and

(d) at the time of the commission of the alleged offence the relevant substance or article was in the same state as when the defendant purchased it.

(3) The provisions are—

(a) regulation 251 (compliance with standards specified in certain publications);

(b) regulations 268, 268A, 269 and 269A (offences relating to packaging and package leaflets);

(d) regulation 275 (colouring of aspirin and paracetamol products for children).

(4) A warranty is not to be a defence under this regulation unless, no later than three clear days before the date of the hearing, the defendant sends to the prosecutor, and to the person who gave the warranty to the defendant—

(a) a copy of the warranty;

(b) a notice stating that the defendant intends to rely on it; and

(5) Where the defendant is an employee of the person who purchased the substance or article under the warranty, the defendant is entitled to rely on the provisions of this regulation in the same way as the employer.

(6) The person by whom the warranty is alleged to have been given is entitled to appear at the hearing and to give evidence.

(7) The court may adjourn the hearing in order to enable a person to appear and give evidence in accordance with paragraph (6).

(8) For the purposes of this regulation, a name or description entered in an invoice is to be deemed to be a written warranty that the article or substance to which the name or description applies can be sold, supplied, or offered or exposed for sale under that name or description without contravening a provision mentioned in paragraph (3).

(9) In the application of this regulation and regulation 337 to Scotland, references to the defendant are to be construed as references to the accused.

Offences in relation to warranties and certificates

337

(1) It is an offence for a defendant in proceedings for an offence under these Regulations in respect of a contravention of a provision mentioned in regulation 336 (3)—

(a) intentionally to apply a warranty given in relation to one substance or article to a different substance or article; or

(b) intentionally to apply to one substance or article a certificate issued under regulation 330 or paragraph 19 of Schedule 31 in relation to a sample of a different substance or article.

(2) A person who intentionally or recklessly gives a purchaser a false warranty certifying a matter specified in regulation 336(2)(a) is guilty of an offence.

(3) If the defendant in proceedings for an offence under these Regulations in respect of a contravention of a provision mentioned in regulation 336(3) relies successfully on a warranty given to the defendant or to the defendant's employer, proceedings for an offence under paragraph (2) may be brought in accordance with paragraph (4).

(4) Proceedings may be brought, as the prosecutor chooses—

(a) before a court which has jurisdiction in the place where a sample of the substance or article to which the warranty relates was taken; or

(b) before a court which has jurisdiction in the place where the warranty was given.

(5) A person guilty of an offence under this regulation is liable—

(a) on summary conviction to a fine not exceeding the statutory maximum; or

(b) on conviction on indictment to a fine or to imprisonment for a term not exceeding two years, or to both.

Offences by bodies corporate and partnerships

338

(1) If an offence under these Regulations committed by a body corporate is proved to have been committed with the consent or connivance of, or to be attributable to neglect on the part of, an officer of the body corporate, or a person purporting to act as an officer of the body corporate, that officer or person (as well as the body corporate) is guilty of the offence and is liable to be proceeded against and punished accordingly.

(2) If the affairs of a body corporate are managed by its members, paragraph (1) applies in relation to the acts and omissions of a member in connection with the member's functions of management as it applies to an officer of the body corporate.

(3) If an offence under these Regulations is—

(a) committed by a Scottish partnership; and

(b) proved to have been committed with the consent or connivance of, or to be attributable to neglect on the part of, a partner of the partnership,

the partner (as well as the partnership) is guilty of the offence and is liable to be proceeded against and punished accordingly.

(4) In this regulation “officer” in relation to a body corporate means a director, secretary or other similar officer of the body corporate.

Prosecutions

339

(1) A magistrates' court in England or Wales may try an information for an offence under these Regulations that is triable only summarily if the information was laid at any time within the period of twelve months beginning with the commission of the offence.

(2) Summary proceedings in Scotland for an offence triable only summarily under these Regulations may be commenced at any time within the period of twelve months beginning with the commission of the offence (and section 136(3) of the Criminal Procedure (Scotland) Act 1995 applies for the purposes of this paragraph as it applies for the purposes of that section).

(3) A magistrates' court in Northern Ireland may hear and determine a complaint for an offence punishable on summary conviction under these Regulations, other than an offence which is also triable on indictment, if the complaint was made at any time within the period of twelve months beginning with the commission of the offence.

(4) A body referred to in regulation 323(2) (enforcement in England, Wales and Scotland) may not institute proceedings for an offence under these Regulations in relation to a contravention of a provision which it may or must enforce by virtue of arrangements made under that regulation unless it has given no less than 28 days' notice of its intention to do so, together with a summary of the facts on which the charges are founded, to the Secretary of State.

(5) A district council (as defined in regulation 324 (enforcement in Northern Ireland)) may not institute proceedings for an offence under these Regulations in relation to a contravention of a provision which it may or must enforce by virtue of arrangements made under regulation 324(2) unless it has given no less than 28 days' notice of its intention to do so, together with a summary of the facts on which the charges are founded, to the Minister for Health, Social Services and Public Safety.

(6) A certificate of the Secretary of State or of the Minister for Health, Social Services and Public Safety that the requirements of paragraph (4) or, as the case may be, (5) have been complied with is to be conclusive evidence that the requirements have been complied with, and a document purporting to be such a certificate is to be presumed to be such a certificate unless the contrary is proved.

General

Presumptions

340

(1) Paragraph (2) applies for the purposes of proceedings under these Regulations for an offence consisting of offering a medicinal product for sale by retail in contravention of regulation 220 (sale or supply of products not subject to general sale) or 221 (sale or supply of products subject to general sale).

(2) If it is proved that the medicinal product in question was found on a vehicle from which medicinal products are sold, it is to be presumed, unless the contrary is proved, that the person in charge of the vehicle offered the medicinal product for sale.

(3) Paragraph (4) applies for the purposes of proceedings under these Regulations for an offence consisting of a contravention of a provision within paragraph (5), where it is proved that the medicinal product in question was found on premises at which the person charged with the offence carries on a business consisting of or including the sale or supply of medicinal products.

(4) It is to be presumed, unless the contrary is proved, that the person charged possessed the medicinal product for the purpose of sale or supply.

(5) The provisions within this paragraph are regulations 268 (offences relating to packaging and package leaflets in Great Britain: authorisation holders), 268A (offences relating to packaging and package leaflets in Northern Ireland: authorisation holders), 269 (offences relating to packaging and package leaflets in Great Britain: other persons), 269A (offences relating to packaging and package leaflets in Northern Ireland: other persons) and 276 (offences: requirements relating to child safety) to the extent that they establish an offence based on possession of a medicinal product for the purpose of sale or supply.

Decisions under these Regulations

341

(1) Where the licensing authority notifies a person of a decision under these Regulations, it must—

(a) state its reasons for the decision; and

(b) inform the person of any action the person may take under these Regulations to challenge that decision and of the time for taking that action.

(2) Paragraph (1) is without prejudice to any other provision of these Regulations concerning notification by the licensing authority.

(3) The licensing authority must publicise any decision under these Regulations to which paragraph (4) applies in such manner as it thinks fit.

(4) Those decisions are—

(a) a decision to grant or revoke a UK marketing authorisation;

(aa) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b) a decision to grant or revoke a certificate of registration; and

Time limits for provision of information etc

342

(1) This regulation applies if—

(a) by any provision of these Regulations a person is required to provide—

(i) any information or document to the licensing authority or to the Ministers, or

(ii) any assistance to the licensing authority or to the Ministers; and

(b) no time is specified in that provision within which the obligation must be performed.

(2) The obligation must be performed within such time as may be specified in a written notice given to the person by the licensing authority or the Ministers (as the case may be).

Service of documents

343

(1) A notice or other document required or authorised by any provision of these Regulations to be served on a person, or to be given or sent to a person, may be served, given or sent—

(a) by delivering it to the person;

(b) by sending it by post to the person's usual or last known residence or place of business in the United Kingdom;

(c) in the case of a body corporate, by delivering it to the secretary or clerk of the body corporate at its registered or principal office or by sending it by post to the secretary or clerk of the body corporate at that office; or

(d) in the case of a Scottish partnership by delivering it to a partner or by sending it by post to the address of the principal office of the partnership; or

(e) if the person consents in writing to the use of electronic communication, by a means of electronic communication.

(2) Where a notice or other document is sent by means of electronic communication it is treated for the purposes of these Regulations as received on the day on which it is sent, unless the contrary is proved.

Payment of expenses by Ministers

344

(1) If a person enforces a provision of these Regulations in accordance with functions conferred under Part 16 (enforcement), the relevant Minister must pay such amounts as the person may reasonably require in respect of expenses incurred in the course of enforcement.

(2) In paragraph (1) “the relevant Minister” means—

(a) in relation to enforcement in England, Wales, and Scotland, the Secretary of State; and

(b) in relation to enforcement in Northern Ireland, the Minister for Health, Social Services and Public Safety.

Immunity from civil liability

345

(1) This regulation applies where the licensing authority makes a recommendation or requirement to which paragraph (2) applies in response to the suspected or confirmed spread of—

(a) pathogenic agents;

(b) toxins;

(d) nuclear radiation,

which may cause harm to human beings.

(2) This paragraph applies to a recommendation or requirement—

(a) for the use of a medicinal product without an authorisation; or

(b) for the use of a medicinal product with an authorisation, but for a therapeutic indication that is not permitted under the authorisation.

(3) None of the following are to be subject to any civil liability for any loss or damage resulting from the use of the product in accordance with the recommendation or requirement—

(a) any holder of an authorisation for the product;

(aa) if there is no holder of an authorisation for the product but the sale or supply of the product is authorised by the licensing authority on a temporary basis under regulation 174, the person responsible for placing the product on the market in the United Kingdom;

(b) any manufacturer of the product;

(d) any health care professional; or

(e) any person, not being a health care professional, who administers the product in accordance with a protocol of the type mentioned in regulation 247A.

(4) This regulation does not apply in relation to liability under section 2 (liability for defective products) of the Consumer Protection Act 1987 or article 5 of the Consumer Protection (Northern Ireland) Order 1987.

(5) In this regulation “authorisation” means a UK marketing authorisation ..., certificate of registration, traditional herbal registration or Article 126a authorisation.

Review

346

(1) The Secretary of State must from time to time carry out a review of the provisions listed in paragraph (2).

(2) Those provisions are—

(a) Chapters 1, 3 and 4 of Part 3;

(b) Parts 11 and 12A;

(ai) 17A,

(bi) 17B,

(i) 18(6),

(ii) 20(1),

(iiza) 27A,

(iizb) 29A,

(iizc) 29B

(iia) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(iii) 37(4)(b), (5), (6), (11) and (12),

(iiiza) 37A,

(iiizb) 37B,

(iiia) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(iv) 43(5), (6)(a) and (d), 7(c)(iii) and (vii), (8) and (12) to (14),

(iva) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(v) 44(1) to (6),

(va) 50K,

(vi) 59,

(vii) 60(3)(b), (9) and (10),

(viii) 61,

(ix) 63,

(x) 64(4)(b), (d) and (e), (5)(a) and (6)(c),

(xi) 65(2),

(xii) 66(5) and (6),

(xiii) 68(2)(a) and (b), (5) and (12A),

(xiv) 69(2)(a) and (b), (5) and (10),

(xiva) 73(5A) to (5C),

(xivb) 74A,

(xivc) 74B,

(xv) 75(2)(b) and (c),

(xvi) 76,

(xvii) 79,

(xviia) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(xviii) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(xix) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(xixa) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(xx) 97,

(xxi) 105(3)(b),

(xxii) 107(2),

(xxiii) 108(5),

(xxiv) 110(8A),

(xxiva) 113(3A),

(xxv) 115(2)(b) and (c),

(xxvi) 132(2),

(xxvii) 133(5) and (6),

(xxviii) 135(10A),

(xxviiia) 142(5A) to (5C),

(xxviiiaza) regulations 167A to 167H,

(xxviiiazb) 170A,

(xxviiiazc) 170B,

(xxviiiaa) regulation 174A,

(xxviiib) 213(3),

(xxviiiba) 214(5C) and (5D),

(xxviiic) 217A,

(xxviiid) 218(2)(b) and (c), (3) and (5),

(xxviiie) 219 and 219A,

(xxviiiezb) 220B,

(xxviiiea) 223(3)(b),

(xxviiieb) 226A,

(xxviiieb) 228(2)(d)(iv),

(xxviiif) 229(1)(db) and (dc) and (2),

(xxviiifa) 233(1)(a)(ivd) and (ive),

(xxviiig) 234(2)(e),

(xxviiiga) regulation 235A,

(xxviiih) 248(1)(a) and (2)(a),

(xxviiii) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(xxviiij) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(xxviiik) 257CA,

(xxix) 266(4) and (5),

(xxx) 327(2)(g) and insofar as the provision relates to active substances paragraphs (1)(c)(iii), (iv) and (viii), (2)(a) to (f), (3), (4) and (6),

(xxxi) 330(1) and (2),

(xxxii) 331, and

(xxxiii) regulation 349 insofar as it repeals section 10(7) of the Medicines Act 1968; and

(d) Schedules—

(i) 5 paragraphs 1(1)(b) to (d), (2)(b) to (d), 3(11)(b)(vi) to (viii), 5(2)(f) to (h),

(ia) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(ii) 7A,

(iii) 8 paragraphs 9A, 12, 13, 19 and 23,

(iv) 12 paragraph 21,

(ivza) 16, Part 2 entries relating to “the United Kingdom Health Security Agency” and “Public Health Agency” and Part 3 entries relating to “search and rescue operations”,

(iva) 17, Part 1 items 12 and 13, Part 2 items ... 11 and 12, Part 3 item 11, Part 4 items 11 to 13 and Part 5 items ... 18 to 20,

(ivaa) 23, paragraph 1(a)(vii) to (x),

(ivab) 24 paragraph 18A,

(ivb) 22, entries relating to “the United Kingdom Health Security Agency”, “Public Health Agency” and “search and rescue operations”, and

(v) 27 paragraphs 14 and 15.

(3) The Secretary of State must—

(a) set out the conclusions of a review carried out in accordance with paragraph (1) in a report; and

(b) publish the report.

(4) In carrying out the review the Secretary of State must, so far as is reasonable, have regard to how—

(a) the 2001 Directive;

(b) Directive 2010/84/EU of the European Parliament and of the Council of 15 October 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use;

(c) Article 11 of Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare;

(d) Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products; and

(e) Commission Implementing Directive 2012/52/EU of 20 December 2012 laying down measures to facilitate the recognition of medical prescriptions issued in another Member State,

are implemented in other member States in relation to the subject matter of the provisions mentioned in paragraph (2).

(5) The report must in particular—

(a) set out the objectives intended to be achieved by the regulatory system established by the provisions of these Regulations that implement those Directives in relation to the subject matter of the provisions mentioned in paragraph (2)(a), (b), (c)(i) to (xxxii) and (d);

(b) assess the extent to which those objectives are achieved; and

(c) assess whether those objectives remain appropriate and, if so, the extent to which they could be achieved with a system that imposes less regulation.

(6) The first report under this regulation must be published before the end of the period of five years beginning with the day on which these Regulations come into force.

(7) Reports under this regulation are afterwards to be published at intervals not exceeding five years.

Transitional provisions, savings, amendments, repeals and revocations

Transitional provisions and savings

347

Schedule 32 contains transitional provisions and savings.

Amendments to existing law

348

Schedule 34 contains amendments to existing law.

Repeals and revocations

349

Schedule 35 contains repeals and revocations.

SCHEDULE 1 — Further provisions for classification of medicinal products

PART 1 — Descriptions of certain medicinal products to be available only on prescription

1

The following medicinal products shall be available only on prescription—

(a) a product for parenteral administration;

(b) a product that is a controlled drug as defined in section 2(1)(a) of the Misuse of Drugs Act 1971, unless it is covered by a UK marketing authorisation in which the product is classified as a pharmacy medicine or as a medicinal product subject to general sale;

(d) medicinal substances that on administration emit radiation, or contain or generate any substance which emits radiation, in order that radiation may be used;

(e) a product that—

(i) is covered by a UK marketing authorisation ..., Article 126a authorisation or parallel import licence in which the product is classified as a pharmacy medicine or as a medicinal product subject to general sale, and

(ii) consists of or contains aloxiprin, aspirin or paracetamol in the form of non-effervescent tablets or capsules;

(f) a product that—

(i) is covered by a UK marketing authorisation ..., Article 126a authorisation or parallel import licence in which the product is classified as a pharmacy medicine or as a medicinal product subject to general sale, and

(ii) consists of or contains (in any pharmaceutical form) pseudoephedrine salts or ephedrine base or salts; ...

(g) a product that—

(i) is not covered by a UK marketing authorisation ..., Article 126a authorisation or parallel import licence, and

(ii) is a prescription only medicine by virtue of articles 5 and 10 of, and Schedules 1 and 2 to, the Prescription Only Medicines (Human Use) Order 1997 ; ...

(h) a product which is authorised by the licensing authority on a temporary basis under regulation 174, in circumstances where the licensing authority has attached a condition to that authorisation to the effect that, for the duration of the temporary authorisation, the product is classified as a prescription only medicine ; and

(i) an EAMS medicinal product, in circumstances where the licensing authority has attached a condition to the EAMS scientific opinion in respect of that product to the effect that, for the duration of that opinion, the product is classified as a prescription only medicine.

2

In this Part “cyanogenic substances” means preparations which—

(a) are presented for sale or supply under the name of, or as containing, amygdalin, laetrile or vitamin B17; or

(b) contain more than 0.1 per cent by weight of any substance having the formula either—

(i) alpha-Cyanobenzyl -6-O-Beta-d-glucopyranosyl -Beta-d-glucopyranoside, or

(ii) alpha-Cyanobenzyl -Beta-d-glucopyranosiduronic acid.

PART 2 — Descriptions of certain medicinal products to be available only from a pharmacy

3

The following medicinal products shall be available only from a pharmacy—

(a) a product comprising eye ointment;

(b) a product that contains Vitamin A, Vitamin A acetate or Vitamin A palmitate, in each case with a maximum daily dose equivalent to more than 7500 international units of Vitamin A or 2250 micrograms of retinol;

(d) a product which is authorised by the licensing authority on a temporary basis under regulation 174, in circumstances where the licensing authority has attached a condition to that authorisation to the effect that, for the duration of the temporary authorisation, it is only to be available from a pharmacy ; and

(e) an EAMS medicinal product, in circumstances where the licensing authority has attached a condition to the EAMS scientific opinion in respect of that product to the effect that, for the duration of that opinion, it is only to be available from a pharmacy.

4

The following medicinal products shall be available only from a pharmacy unless they are the subject of a UK marketing authorisation ..., Article 126a authorisation, parallel import licence or traditional herbal registration that classifies them as medicinal products subject to general sale—

(a) a product that is for use as an anthelmintic;

(b) a product that is for parenteral administration;

(d) a product that is for use wholly or mainly for irrigation of—

(i) wounds, or

(ii) the bladder, vagina or rectum;

(e) a product that is for administration wholly or mainly to children being a preparation of aloxiprin or aspirin.

5

A medicinal product shall be available only from a pharmacy if it is a medicinal product of a kind specified in Schedule 15 but is not presented for sale in accordance with the requirements specified in that Schedule for a product of that kind to be subject to general sale.

SCHEDULE 2 — Supplementary provision relating to advisory bodies and expert advisory groups

Terms of appointment

1

(1) The person appointed to chair an advisory body is to hold and vacate office in accordance with the written terms of the appointment (but this is subject to sub-paragraphs (2) and (3)).

(2) The person's term of office as chair of the advisory body is not to exceed the person's term of office as a member of the body.

(3) The person may resign from chairing the advisory body at any time by notice in writing to the Ministers.

2

(1) A member of an advisory body, other than its chair, is to hold and vacate office in accordance with the written terms of the appointment (but this is subject to sub-paragraphs (2) and (3)).

(2) The term of an appointment may not exceed four years (but an appointment may be renewed).

(3) A member of an advisory body may resign from it at any time by notice in writing to the Ministers.

(4) Where a person ceases to be a member of an advisory body, the person also ceases to be a member of any expert advisory group appointed by the advisory body (including an expert advisory group appointed jointly with the other advisory body).

(5) But sub-paragraph (4) does not apply if—

(a) the person was a member of the advisory body only by virtue of being co-opted under regulation 13; or

(b) the person is immediately re-appointed to the advisory body.

3

(1) The person appointed to chair an expert advisory group is to hold and vacate office in accordance with the written terms of the appointment (but this is subject to sub-paragraphs (2) and (3)).

(2) The person's term of office as chair of the expert advisory group is not to exceed the person's term of office as a member of the group.

(3) The person may resign from chairing the group at any time by notice in writing to the advisory body or bodies which appointed the group.

4

(1) This paragraph applies to a member of an expert advisory group, other than a person appointed to chair an expert advisory group.

(2) The member is to hold and vacate office in accordance with the written terms of the appointment (but this is subject to sub-paragraphs (3) and (4)).

(3) The term of an appointment may not exceed four years (but an appointment may be renewed).

(4) The member may resign office at any time by notice in writing to the advisory body or bodies which appointed the group.

Facilities and proceedings

5

The Ministers must provide each advisory body with such staff, accommodation, services and other facilities as the Ministers think necessary or expedient for the proper performance of its functions.

6

The validity of any proceedings of an advisory body or expert advisory group is not affected by—

(a) a vacancy among its members; or

(b) a defect in the appointment of any member.

7

(1) An advisory body may, subject to approval by the Secretary of State, make such provision as it thinks fit for the regulation of its own proceedings.

(2) The licensing authority may make provision for the regulation of the proceedings of an expert advisory group.

Payment and expenses

8

The Ministers may pay to the members of each advisory body and expert advisory group such remuneration (if any) and such allowances as may be determined by the Ministers with the consent of the Treasury.

9

The Ministers must defray any expenses incurred with their approval by each advisory body and expert advisory group.

10

If an action is brought against a person arising out of an act performed as a member of an advisory body or expert advisory group, the Ministers may indemnify that person against any damages, costs or expenses incurred in that action.

11

Paragraphs 8 to 10 shall have effect in relation to an expert committee appointed by the licensing authority and to its members as if they were an advisory body or expert advisory group and its members.

Status

12

An advisory body or expert advisory group is not to be regarded—

(a) as a servant or agent of the Crown; or

(b) as enjoying any status, immunity or privilege of the Crown.

SCHEDULE 3 — Applications for licences under Part 3

Manufacturer’s licences

1

(1) This paragraph applies to an application for a manufacturer's licence relating to the manufacture or assembly of medicinal products.

(2) The application must contain—

(a) the name and address of the applicant;

(b) the name and address of the person (if any) making the application on the applicant's behalf;

(c) except where the operations will relate to an MM medicinal product or a POC medicinal product, the address of each of the premises where any operations to which the licence relates are to be carried out;

(ca) where the application relates to an MM medicinal product, the address of the MM control site;

(cb) where the application relates to a POC medicinal product, the address of the POC control site;

(d) the address of any premises not mentioned by virtue of paragraph (c) , (ca) or (cb) where—

(i) the applicant proposes to keep any living animals, from which a substance used in the production of the medicinal product to which the application relates is to be derived, or

(ii) materials of animal origin, from which a substance is to be derived as mentioned in sub-paragraph (i), are to be kept;

(e) the address of each of the premises where medicinal products are to be stored, or from which medicinal products are to be distributed;

(f) the name, address, qualifications and experience of the person (“S”) whose duty it will be to supervise the manufacturing or assembling operations, and the name and job title of the person to whom S reports;

(g) the name, address, qualifications and experience of the person with responsibility for quality control in relation to the medicinal products to be manufactured or assembled under the licence (and, if that responsibility is to be carried out by the holder of—

(i) in the case of a product for sale or supply in Great Britain, the UK marketing authorisation, certificate of registration or traditional herbal registration relating to the products, or

(ii) in the case of a product for sale or supply in Northern Ireland, the marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration relating to the products,

a statement of that fact);

(h) the name, address and qualifications of the person to be responsible for any animals kept as mentioned in sub-paragraph (d)(i);

(i) the name, address and qualifications of the person to be responsible for the culture of any living tissue for use in the manufacture of medicinal products;

(j) the name, address and qualifications of the qualified person.

(3) The application must also contain—

(a) the pharmaceutical form of each medicinal product to be manufactured or assembled;

(b) details of the manufacturing or assembling operations to which the licence is to relate, including a statement of whether they include—

(i) the manufacture of medicinal products, or

(ii) the assembly of medicinal products;

(ba) a statement of whether any of the medicinal products to be manufactured or assembled are MM medicinal products or POC medicinal products;

(i) being administered to human beings in that form, or

(ii) as an ingredient in the preparation of another medicinal product;

(d) a statement of the facilities and equipment available at each of the premises where medicinal products are to be stored, or from which medicinal products are to be distributed;

(e) a separate statement, in respect of each of the premises mentioned in the application, of—

(i) the manufacturing or assembling operations capable of being carried out at those premises, and the class of medicinal products to which those operations relate, and

(ii) the equipment available at those premises for carrying out each stage of those operations;

(f) a statement of the authority conferred on the person mentioned in sub-paragraph (2)(g) to reject unsatisfactory medicinal products;

(g) a description of the arrangements for the identification and storage of materials and ingredients before and during manufacture or assembly and for the storage of medicinal products after manufacture or assembly;

(h) a description of the arrangements, at each of the premises where the applicant proposes to store medicinal products, for ensuring, so far as practicable, the turn-over of stocks of medicinal products;

(i) a description of the arrangements for maintaining—

(i) production records, and

(ii) records of analytical and other tests used in the course of manufacture or assembly for ensuring compliance of materials used in manufacture, or of medicinal products, with the specification for such materials or medicinal products;

(j) a description of the arrangements for keeping reference samples of—

(i) materials used in the manufacture of medicinal products, and

(ii) medicinal products;

(k) where the application relates to an exempt advanced therapy medicinal product, an outline of the arrangements for maintaining records to allow product traceability containing sufficient detail to enable the linking of a product to the patient who received it and vice versa; and

(l) details of—

(i) any manufacturing operations, other than those to which the licence is to relate, carried on by the proposed licence holder on or near the premises mentioned in sub-paragraph (2)(c), and

(ii) the substances or articles to which those operations relate.

Manufacturers’ licence relating to import

2

(1) This paragraph applies to an application for a manufacturer's licence relating to the import from—

(a) in the case of an import into Great Britain, a country other than Northern Ireland or a country other than an approved country for import, or

(b) in the case of an import into Northern Ireland, a country other than an EEA State,

of medicinal products.

(2) The application must contain—

(a) the name and address of the applicant;

(b) the name and address of the person (if any) making the application on the applicant's behalf;

(c) the name, pharmaceutical form, country of origin and marketing authorisation number of each imported medicinal product;

(d) the address of each set of premises where the importation operation is to take place;

(e) the address of each set of premises where any testing associated with the importation is to take place;

(f) the address of each set of premises where medicinal products are to be stored, or from which they are to be distributed;

(g) the name, address and qualifications of the qualified person; and

(h) the name, address, qualifications and experience of the person in charge of quality control.

(3) The application must also contain—

(a) details of the importation operations to which the licence is to relate;

(b) a statement of the facilities and equipment available at each set of premises where medicinal products are to be stored, or from which they are to be distributed;

(i) any manufacturing of medicinal products carried on by the applicant on or near the premises mentioned in sub-paragraph (2)(d) to (f), and

(ii) the substances or articles manufactured or used in the manufacturing;

(d) a description of the arrangements for storage of the medicinal products after importation;

(e) a description of the arrangements at each set of premises for ensuring, so far as practicable, the turn-over of stocks of medicinal products;

(f) a description of the arrangements for maintaining—

(i) records of importation, and

(ii) records of analytical and other procedures applied in the course of importation; and

(g) a description of the arrangements for keeping reference samples of the medicinal products.

Wholesale dealer’s licences

3

(1) This paragraph applies to an application for a wholesale dealer's licence.

(2) The application must contain—

(a) the name and address of the applicant;

(b) the name and address of the person (if any) making the application on the applicant's behalf;

(c) the address of each of the premises where medicinal products are to be stored, or from which they are to be distributed; and

(d) the name, address and qualifications of the responsible person or the responsible person (import).

(3) The application must also contain—

(a) details of the distribution by way of wholesale dealing to which the licence is to relate;

(b) a statement of whether the medicinal products to which the distribution relates are the subject of—

(i) in the case of a product for sale or supply in Great Britain, a UK marketing authorisation,

(ia) in the case of a product for sale or supply in Northern Ireland, a marketing authorisation,

(ii) a certificate of registration,

(iii) a traditional herbal registration, or

(iv) in the case of a product for sale or supply in Northern Ireland, an Article 126a authorisation;

(v) an authorisation granted by an authority in a country other than the United Kingdom to sell or supply the medicinal product in that other country;

(i) prescription only medicines,

(ii) pharmacy medicines, or

(iii) medicines subject to general sale;

(d) a statement of whether the medicinal products to which the distribution relates are—

(i) special medicinal products, ...

(ia) EAMS medicinal products,

(ii) sold or supplied pursuant to regulation 174 (supply in response to spread of pathogenic agents etc), or

(iii) to be distributed by means of export from Great Britain to an approved country for import;

(e) a statement of whether the medicinal products dealt in under the licence are to be used—

(i) for administration to human beings, or

(ii) as ingredients in the preparation of medicinal products for administration to human beings;

(f) an indication of the range of medicinal products to be stored at each of the premises mentioned in the application;

(g) a statement of the facilities and equipment available at those premises for storing and distributing medicinal products;

(h) a description of the arrangements at those premises for ensuring, so far as practicable, the turn-over of stocks of medicinal products (whether by the maintenance of records or by other means);

(i) details of an emergency plan which satisfies the requirements of regulation 43(7)(b), and

(j) a description of the arrangements for keeping records relating to products received or dispatched.

(4) In sub-paragraph (2)(d)—

“the responsible person” means the person who has the functions described in regulation 45(2);

“the responsible person (import)” means the person who has the functions described in regulation 45AA(4).

All licences

4

(1) If an application does not include information or other matters required under this Schedule, the application must state—

(a) why that information is not applicable; or

(b) any other reason for not including them.

(2) An application for a licence must be in English.

(3) The pages of an application for a licence must be serially numbered.

(4) The applicant must sign the application.

(5) If the application is made by another person on behalf of the applicant, that person must also sign the application.

SCHEDULE 4 — Standard provisions of licences under Part 3

PART 1 — Manufacturer's licence relating to manufacture and assembly

1

The provisions of this Part are standard provisions of a manufacturer's licence relating to the manufacture or assembly of medicinal products.

2

The licence holder must place the quality control system referred to in Article 11(1) of the Good Manufacturing Practice Directive under the authority of the person notified to the licensing authority in accordance with paragraph 1(2)(g) of Schedule 3.

3

The licence holder may use a contract laboratory pursuant to Article 11(2) of the Good Manufacturing Practice Directive if the laboratory is operated by a person approved by the licensing authority.

4

The licence holder must provide such information as may be requested by the licensing authority—

(a) about the products currently being manufactured or assembled by the licence holder; and

(b) about the operations being carried out in relation to such manufacture or assembly.

5

The licence holder must inform the licensing authority of any change that the licence holder proposes to make to a person named in the licence as—

(a) the person whose duty it is to supervise the manufacturing or assembling operations;

(b) in charge of the animals from which are derived substances used in the production of the medicinal products being manufactured or assembled; or

(c) responsible for the culture of living tissues used in the manufacture of the medicinal products being manufactured or assembled.

6

The licence holder must—

(a) keep readily available for inspection by a person authorised by the licensing authority the batch documentation referred to in Article 9(1) of the Good Manufacturing Practice Directive; and

(b) permit the authorised person to take copies or make extracts from such documentation.

7

The licence holder must keep readily available for examination by a person authorised by the licensing authority the samples in each batch of finished medicinal product referred to in Article 11(4) of the Good Manufacturing Practice Directive.

8

Where the licence holder has been informed by the licensing authority that the strength, quality or purity of a batch of a medicinal product to which the licence relates has been found not to conform with—

(a) the specification for the finished product; or

(b) the provisions of these Regulations applicable to the medicinal product,

the holder must, if so directed, withhold the batch from distribution, so far as reasonably practicable, for a period (not exceeding six weeks) specified by the licensing authority.

9

The licence holder must ensure that tests for determining conformity with the standards and specifications applying to a product used in the manufacture of a medicinal product must, except so far as the conditions of the product specification for that product otherwise provide, be applied to samples taken from the medicinal product after all manufacturing processes have been completed, or at such earlier stage of the manufacture as may be approved by the licensing authority.

10

Where the manufacturer's licence relates to the assembly of a medicinal product or class of product, and the licence holder supplies the product at such a stage of assembly that does not fully comply with the provisions of the product specification which relate to labelling, the licence holder must communicate the particulars of those provisions to the person to whom that product has been supplied.

11

Where—

(a) the manufacturer's licence relates to the assembly of a medicinal product;

(b) the medicinal product is not manufactured by the licence holder; and

(c) particulars of the name and address of the manufacturer of the product, or the person who imports the product, have been given by the licence holder to the licensing authority,

the licence holder must immediately notify the licensing authority in writing of any changes in the particulars.

12

The licence holder must keep readily available for examination by a person authorised by the licensing authority durable records of the details of the manufacture of intermediate products held by the licence holder for use in the manufacture of biological medicinal products, and the records must—

(a) be in such form as to ensure that the licence holder has a comprehensive record of all matters that are relevant to an evaluation of the safety, quality and efficacy of a finished biological medicinal product manufactured using those intermediate products; and

(b) not be destroyed without the consent of the licensing authority until the records of the details of manufacture of finished medicinal products which were or may be manufactured using those intermediate products may be destroyed in accordance with the requirements of these Regulations.

13

Where—

(a) animals are used in the production of medicinal products; and

(b) in the case of a product for sale or supply—

(i) in Great Britain, a UK marketing authorisation, certificate of registration or traditional herbal registration, or

(ii) in Northern Ireland, a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration,

contains provisions relating to them,

the manufacturer's licence holder must arrange for the animals to be housed in such premises, and managed in such a manner, as facilitates compliance with those provisions.

14

The licence holder must take all reasonable precautions and exercise all due diligence to ensure that any information provided to the licensing authority is not false or misleading in any material particular if—

(a) it relates to a medicinal product which the licence holder manufactures or assembles; or

(b) it relates to any starting materials or intermediate products held by the licence holder which are for use in the manufacture of medicinal products.

PART 2 — Manufacturer's licence relating to the import of medicinal products from a state other than an EEA State / Country other than an Approved Country for Import

15

The provisions of this Part are standard provisions of a manufacturer's licence relating to the import of medicinal products from—

(a) in the case of an import into Great Britain, a country other than Northern Ireland or a country other than an approved country for import, or

(b) in the case of an import into Northern Ireland, a country other than an EEA State.

16

17

The licence holder may use a contract laboratory pursuant to Article 11(2) of the Good Manufacturing Practice Directive if operated by a person approved by the licensing authority.

18

The licence holder must provide such information as may be requested by the licensing authority concerning the type and quantity of any medicinal products which the licence holder imports.

19

The licence holder must—

(a) keep readily available for inspection by a person authorised by the licensing authority the batch documentation referred to in Article 9(1) of the Good Manufacturing Practice Directive; and

(b) permit the person authorised to take copies or make extracts from such documentation.

20

(a) the specification of the medicinal product in question; or

(b) those provisions of these Regulations that are applicable to the medicinal product,

the licence holder must, if so directed, withhold the batch from distribution, so far as reasonably practicable, for such a period (not exceeding six weeks) as may be specified by the licensing authority.

21

The licence holder must ensure that any tests for determining conformity with the standards and specifications applying to any ingredient used in the manufacture of a medicinal product must, except so far as the conditions of the product specification for that ingredient otherwise provide, be applied to samples taken from the medicinal product after all manufacturing processes have been completed, or at such earlier stage in the manufacture as may be approved by the licensing authority.

22

(1) Where and in so far as the licence relates to special medicinal products, the licence holder may only import such products from , in the case of an import into Great Britain, a country other than Northern Ireland or a country other than an approved country for import and in the case of an import into Northern Ireland, a country other than an EEA State—

(a) in response to an order which satisfies the requirements of regulation 167 (supply to fulfil special patient needs); and

(b) where the conditions set out in sub-paragraphs (2) to (9) are complied with.

(2) No later than 28 days before the day on which each importation of a special medicinal product takes place, the licence holder must give written notice to the licensing authority stating the intention to import the product and stating the following particulars—

(a) the brand name, common name or scientific name of the medicinal product and (if different) any name under which the medicinal product is to be sold or supplied in the United Kingdom;

(b) any trademark or the name of the manufacturer of the medicinal product;

(c) in respect of each active constituent of the medicinal product, any international non-proprietary name or the British approved name or the monograph name, or where that constituent does not have any of those, the accepted scientific name or any other name descriptive of the true nature of the constituent;

(d) the quantity of medicinal product to be imported, which must not exceed the quantity specified in sub-paragraph (6); and

(e) the name and address of the manufacturer or assembler of the medicinal product in the form in which it is to be imported and, if the person who will supply the medicinal product for importation is not the manufacturer or assembler, the name and address of the supplier.

(3) The licence holder may not import the special medicinal product if, before the end of 28 days beginning immediately after the date on which the licensing authority sends or gives the licence holder an acknowledgement in writing by the licensing authority that it has received the notice referred to in sub-paragraph (2), the licensing authority has notified the licence holder in writing that the product should not be imported.

(4) The licence holder may import the special medicinal product referred to in the notice where the licence holder has been notified in writing by the licensing authority, before the end of the 28-day period referred to in sub-paragraph (3) that the product may be imported.

(5) Where the licence holder sells or supplies special medicinal products or EAMS medicinal products, the licence holder must, in addition to any other records which are required by the provisions of the licence, make and maintain written records relating to—

(a) the batch number of the batch of the product from which the sale or supply was made; and

(b) details of any adverse reaction to the product sold or supplied of which the licence holder becomes aware.

(6) The licence holder must not, on any one occasion, import more than such amount as is sufficient for 25 single administrations, or for 25 courses of treatment where the amount imported is sufficient for a maximum of three months' treatment, and must not, on any one occasion, import more than the quantity notified to the licensing authority under sub-paragraph (2)(d).

(7) The licence holder must not publish any advertisement, catalogue or circular relating to a special medicinal product or EAMS medicinal product or make any representations in respect of that product.

(8) The licence holder must inform the licensing authority immediately of any matter coming to the licence holder's attention which might reasonably cause the licensing authority to believe that a special medicinal product or EAMS medicinal product imported in accordance with this paragraph can no longer be regarded as a product which can safely be administered to human beings or as a product which is of satisfactory quality for such administration.

(9) The licence holder must cease importing or supplying a special medicinal product or EAMS medicinal product if the licence holder receives a notice in writing from the licensing authority directing that, from a date specified in the notice, a particular product or class of products may no longer be imported or supplied.

(10) In this paragraph—

“British approved name” means the name which appears in the current edition of the list prepared by the British Pharmacopoeia Commission under regulation 318 (British Pharmacopoeia: lists of names);

“international non-proprietary name” means a name which has been selected by the World Health Organisation as a recommended international non-proprietary name and in respect of which the Director-General of the World Health Organisation has given notice to that effect in the World Health Organisation Chronicle; and

“monograph name” means the name or approved synonym which appears at the head of a monograph in the current edition of the British Pharmacopoeia, the European Pharmacopoeia or a foreign or international compendium of standards and “current” in this definition means current at the time the notice is sent to the licensing authority.

23

The licence holder must take all reasonable precautions and exercise due diligence to ensure that any information provided to the licensing authority which is relevant to an evaluation of the safety, quality or efficacy of a medicinal product for human use which is imported from , in the case of an import into Great Britain, a country other than Northern Ireland or a country other than an approved country for import and in the case of an import into Northern Ireland, a country other than an EEA State, handled, stored or distributed under the licence is not false or misleading in a material particular.

PART 3 — Manufacturer's licence relating to exempt advanced therapy medicinal products

24

The provisions of paragraphs 25 to 27 are incorporated as additional standard provisions of a manufacturer's licence relating to the manufacture and assembly of exempt advanced therapy medicinal products.

25

The licence holder must ensure that the immediate packaging of an exempt advanced therapy medicinal product is labelled to show the following particulars—

(a) the name of the exempt advanced therapy medicinal product;

(b) the expiry date in clear terms including the year and month and, if applicable, the day;

(d) where the product contains cells or tissues of human or animal origin—

(i) a statement that the product contains such cells or tissues, and

(ii) a short description of the cells or tissues and of their specific origin;

(e) the pharmaceutical form and the contents by weight, volume or number of doses of the product;

(f) a list of excipients, including preservative systems;

(g) the method of use, application, administration or implantation and, if appropriate, the route of administration, with space provided for the prescribed dose to be indicated;

(h) any special storage precautions;

(i) specific precautions relating to the disposal of the unused product or waste derived from the product and, where appropriate, reference to any appropriate collection system;

(j) the name and address of the holder of the manufacturer's licence;

(k) the manufacturer's licence number;

(l) the manufacturer's batch number;

(m) the unique donation code assigned by a tissue establishment pursuant to—

(a) paragraph 1 of Schedule 3A to the Human Fertilisation and Embryology Act 1990, as regards human gametes and embryos; and

(b) paragraph 1 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007, as regards other human tissues and cells; and

(n) where the exempt advanced therapy medicinal product is for autologous use, the unique patient identifier and the words “for autologous use only”.

26

The licence holder must ensure that the package leaflet of the exempt advanced therapy medicinal product shall include the following particulars—

(a) the name of the exempt advanced therapy medicinal product;

(b) the intended effect of the medicinal product if correctly used, applied, administered or implanted;

(i) a statement that the product contains such cells or tissues, and

(ii) a short description of the cells or tissues and, where such cells or tissues are of animal origin, their specific origin;

(d) where the product contains a medical device or an active implantable medical device, a description of that device and, where that device contains cells or tissues of animal origin, their specific origin;

(e) any necessary instructions for use, including—

(i) the posology,

(ii) the method of use, application, administration or implantation and, if appropriate, the route of administration,

(iii) a description of symptoms of overdose,

(iv) action to be taken in the event of overdose, including any emergency procedures,

(v) action to be taken if one or more doses have been missed, and

(vi) a recommendation to consult the doctor or pharmacist for any clarification on the use of the product;

(f) where adverse reactions are known, a description of those which may occur under recommended conditions of use of the product and, if appropriate, an indication of action to be taken in such a case;

(g) an instruction that the patient report any adverse reaction not specified in the package leaflet to the doctor or pharmacist;

(h) the expiry date in clear terms and a warning against using the product after that date;

(i) any special storage precautions;

(j) a description of any visible signs of deterioration;

(k) a complete qualitative and quantitative composition;

(l) the name and address of the holder of the manufacturer's licence; and

(m) the date on which the package leaflet was last revised.

27

The licence holder must keep the data referred to in paragraph 8 of Schedule 6 for such period, being a period of longer than 30 years, as may be specified by the licensing authority.

PART 4 — Wholesale dealer's licence

All wholesale dealer's licences

28

The provisions of this Part are standard provisions of a wholesale dealer's licence.

29

The licence holder must not use any premises for the handling, storage or distribution of medicinal products other than those specified in the licence or notified to the licensing authority from time to time and approved by the licensing authority.

30

The licence holder must provide such information as may be requested by the licensing authority concerning the type and quantity of medicinal products which the licence holder handles, stores or distributes.

31

The licence holder must take all reasonable precautions and exercise all due diligence to ensure that any information provided by the licence holder to the licensing authority which is relevant to an evaluation of the safety, quality or efficacy of a medicinal product which the licence holder handles, stores or distributes is not false or misleading.

Wholesale dealer's licence relating to special medicinal products

32

The provisions of paragraphs 33 to 42 are incorporated as additional standard provisions of a wholesale dealer's licence relating to special medicinal products.

33

Where and in so far as the licence relates to special medicinal products, the licence holder may only import such products from , in the case of an import into Great Britain, an approved country for import and in the case of an import into Northern Ireland, an EEA State—

(a) in response to an order which satisfies the requirements of regulation 167, and

(b) where the conditions set out in paragraphs 34 to 41 are complied with.

34

No later than 28 days prior to each importation of a special medicinal product, the licence holder must give written notice to the licensing authority stating the intention to import the product and stating the following particulars—

(a) the brand name, common name or scientific name of the medicinal product and (if different) any name under which the medicinal product is to be sold or supplied in the United Kingdom;

(b) any trademark or the name of the manufacturer of the medicinal product;

(c) in respect of each active constituent of the medicinal product, any international non-proprietary name or the British approved name or the monograph name, or where that constituent does not have any of those, the accepted scientific name or any other name descriptive of the true nature of the constituent;

(d) the quantity of medicinal product to be imported, which must not exceed the quantity specified in paragraph 38; and

(e) the name and address of the manufacturer or assembler of the medicinal product in the form in which it is to be imported and, if the person who will supply the medicinal product for importation is not the manufacturer or assembler, the name and address of the supplier.

35

The licence holder may not import the special medicinal product if, before the end of 28 days beginning immediately after the date on which the licensing authority sends or gives the licence holder an acknowledgement in writing by the licensing authority that it has received the notice referred to in paragraph 34, the licensing authority has notified the licence holder in writing that the product should not be imported.

36

The licence holder may import the special medicinal product referred to in the notice where the licence holder has been notified in writing by the licensing authority, before the end of the 28-day period referred to in paragraph 35, that the product may be imported.

37

Where the licence holder sells or supplies special medicinal products or EAMS medicinal products, the licence holder must, in addition to any other records which are required by the provisions of the licence, make and maintain written records relating to—

(a) the batch number of the batch of the product from which the sale or supply was made; and

(b) details of any adverse reaction to the product sold or supplied of which the licence holder becomes aware.

38

The licence holder must not, on any one occasion, import more than such amount as is sufficient for 25 single administrations, or for 25 courses of treatment where the amount imported is sufficient for a maximum of three months' treatment, and must not, on any one occasion, import more than the quantity notified to the licensing authority under paragraph 34(d).

39

The licence holder must inform the licensing authority immediately of any matter coming to the licence holder's attention which might reasonably cause the licensing authority to believe that a special medicinal product or EAMS medicinal product imported in accordance with this paragraph can no longer be regarded as a product which can safely be administered to human beings or as a product which is of satisfactory quality for such administration.

40

The licence holder must not publish any advertisement, catalogue, or circular relating to a special medicinal product or EAMS medicinal product or make any representations in respect of that product.

41

The licence holder must cease importing or supplying a special medicinal product or EAMS medicinal product if the licence holder receives a notice in writing from the licensing authority directing that, from a date specified in the notice, a particular product or class of products may no longer be imported or supplied.

42

In this Part—

“British approved name” means the name which appears in the current edition of the list prepared by the British Pharmacopoeia Commission under regulation 318 (British Pharmacopoeia- lists of names);

“international non-proprietary name” means a name which has been selected by the World Health Organisation as a recommended international non-proprietary name and in respect of which the Director-General of the World Health Organisation has given notice to that effect in the World Health Organisation Chronicle; and

“monograph name” means the name or approved synonym which appears at the head of a monograph in the current edition of the British Pharmacopoeia, the European Pharmacopoeia or a foreign or international compendium of standards, and “current” in this definition means current at the time the notice is sent to the licensing authority.

Wholesale dealer's licence relating to exempt advanced therapy medicinal products

43

The provisions of paragraph 44 are incorporated as additional standard provisions of a wholesale dealer's licence relating to exempt advanced therapy medicinal products.

44

The licence holder shall keep the data referred to in paragraph 16 of Schedule 6 for such period, being a period of longer than 30 years, as may be specified by the licensing authority.

SCHEDULE 5 — Review upon oral representations

Application of this Schedule

1

(1) This Schedule applies if a person (“the applicant”) mentioned in sub-paragraph (2) notifies the licensing authority that the applicant wishes the licensing authority to submit the proposal or as the case may be the decision to review upon oral representations under—

(a) regulation 27(3)(b);

(b) regulation 45H(3)(b);

(d) regulation 256J(4)(b); or

(e) Part 1, 2 or 3 of Schedule 11.

(2) Those persons are—

(a) in respect of notification under regulation 27(3)(b) the licence holder;

(b) in respect of a notification under regulation 45H(3)(b) the person registered as a broker;

(d) in respect of a notification under regulation 256J(4)(b) the person on the list in accordance with Part 12A; and

(e) in respect of a notification under Part 1, 2 or 3 of Schedule 11—

(i) an applicant for a UK marketing authorisation, parallel import licence, certificate of registration or traditional herbal registration,

(ii) an applicant for the renewal of an authorisation, licence, certificate or registration, and

(iii) the holder of an authorisation, licence, certificate or registration.

Appointment of reviewers

2

(1) The licensing authority must—

(a) appoint a panel of at least two persons (“the reviewers”) to conduct the review; and

(b) provide facilities for the applicant to have the opportunity to appear before the reviewers.

(2) A person must not be appointed under sub-paragraph (1) if within the period of one year immediately preceding that time the person has been a member of—

(a) the Commission;

(b) an expert committee appointed by the licensing authority;

(d) the British Pharmacopoeia Commission or any of its sub-committees;

(e) the Advisory Board on the Registration of Homoeopathic Products formerly established under section 4 of the Medicines Act 1968; or

(f) the Herbal Medicines Advisory Committee formerly established under section 4 of the Medicines Act 1968.

(3) A person appointed under sub-paragraph (1) must not be an officer or servant of a Minister of the Crown, the Scottish Ministers, the Welsh Ministers or a Northern Ireland Minister.

Procedure before hearing

3

(1) The applicant must supply the reviewers with a written summary of the oral representations that the applicant wishes to make and any documents on which the applicant wishes to rely in support of them before the end of the period of three months beginning with the date of the notification mentioned in paragraph 1.

(2) The reviewers may, at the request of the applicant and after consulting the licensing authority, extend the period mentioned in sub-paragraph (1) up to a maximum of six months beginning with the date of that notification.

(3) The applicant may submit additional written representations or documents after the end of the periods for doing so only with the permission of the reviewers.

(4) In the case of a decision or a proposal by the licensing authority under Part 1, 2 or 3 of Schedule 11, the representations and documents referred to in paragraphs (1) and (3)—

(a) must not be based on any evidence or data that was not available to the licensing authority at the time that the decision or, as the case may be, the proposal that is the subject of the review was notified to the applicant by the licensing authority; unless

(b) the evidence or data is unfavourable in respect of the safety, quality or efficacy of the product concerned.

(5) The reviewers must notify the applicant and the licensing authority of the date of the hearing at least 28 days before that date, unless the applicant and the licensing authority agree to a shorter period of notice.

(6) The reviewers may establish at any stage of the procedures described in this Schedule a date by which all of those procedures, except for the hearing, must be completed, and notify this date to the applicant and to the licensing authority.

(7) The date established under sub-paragraph (6) must not be earlier than whichever is the earlier of—

(a) the first day after the end of the period of three months beginning with the date of the notification mentioned in paragraph 1; or

(b) the first day after the end of the period of 28 days beginning with the date on which the reviewers receive the written summary of the oral representations and supporting documents submitted in accordance with sub-paragraphs (1) and (3) of this paragraph,

and in any case not earlier than the first day after the period of seven days beginning on the day after the notification under sub-paragraph (6).

(8) A date established under sub-paragraph (6) may be varied or withdrawn on the application of the applicant or of the licensing authority.

(9) In the case of a decision or a proposal by the licensing authority under Part 1, 2 or 3 of Schedule 11, the reviewers must not take into account any documents or other evidence, or any representations based on such documents or evidence, in the conduct of the hearing if it thinks that the data or evidence on which the documents or representations are based, or the evidence that is presented, were not available to the licensing authority at the time when the decision or, as the case may be, the proposal that is the subject of the review was notified to the applicant by the licensing authority, unless the evidence or data is unfavourable in respect of the safety, quality or efficacy of the product concerned.

(10) The reviewers may give such other directions as they think fit for the conduct of the hearing, including—

(a) the postponing or adjournment of the hearing for such period as it may decide; and

(b) establishing a list of documents that will be taken into account in the conduct of the hearing.

(11) If the applicant fails to comply with a time limit under sub-paragraph (1), (2) or (6)—

(a) the applicant may not appear before the reviewers; and

(b) the licensing authority must decide whether—

(i) to proceed with its proposal to revoke, vary or suspend the licence,

(ii) to confirm or alter its decision,

(iii) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(iv) to grant or renew the UK marketing authorisation, parallel import licence, certificate of registration or traditional herbal registration or to do so otherwise than in accordance with the application, ...

(v) to revoke, vary or suspend the authorisation, licence, certificate or registration,

(vi) to proceed to suspend, vary or remove the person’s broker registration,

(vii) ro proceed to suspend, vary or remove the person’s active substance registration, or

(viii) to proceed to suspend, vary or remove the person’s entry on the list,

as the case may be.

(12) The licensing authority must notify the applicant of its decision.

Procedure at hearing

4

(1) Both the applicant and the licensing authority may make representations at the hearing.

(2) The hearing must be in public if the applicant so requests.

(3) If the applicant fails to appear at the hearing, the reviewers may conduct the review on the basis of the applicant's written summary of the oral representations and supporting documents submitted in accordance with sub-paragraphs (1), (2) and (3) of paragraph 3.

Procedure following hearing

5

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