The Human Medicines Regulations 2012

Application for UKMA(NI) relating to certain medicinal products that do not qualify as generic etc

Application for UKMA(GB) relating to certain medicinal products that do not qualify as generic etc

Application for UKMA(UK) relating to certain medicinal products that do not qualify as generic etc.

Application for UKMA(NI) relating to similar biological medicinal products

Application for UKMA(GB) relating to similar biological medicinal products

Application for UKMA(UK) relating to similar biological medicinal products

Applications relating to products in well-established medicinal use

Applications relating to new combinations of active substances

Applications containing information supplied in relation to another product with consent

Obligation to update information supplied in connection with parallel import licence application

74A

The holder of a UK marketing authorisation relating to an MM medicinal product must provide the holder of the manufacturer’s licence (MM) relating to that product with information in order to enable the licence holder to ensure that the manufacturer’s licence (MM) and MM master file relating to the product are consistent with the marketing authorisation at all times.

Obligation to provide information relating to methods of manufacture and control: POC medicinal products

74B

The holder of a UK marketing authorisation relating to a POC medicinal product must provide the holder of the manufacturer’s licence (POC) relating to that product with information in order to enable the licence holder to ensure that the manufacturer’s licence (POC) and POC master file relating to the product are consistent with the marketing authorisation at all times.

Obligation to provide information relating to safety etc

Obligation in relation to product information

Record-keeping obligations

Obligation to ensure appropriate and continued supplies

Post authorisation requirements in relation to UK marketing authorisations to which paediatric specific provisions apply

Post authorisation requirements in relation to UKMA(UK)(Category 1) for advanced therapy medicinal products

MM medicinal products: pharmacovigilance requirements

170A

• (1) Where the sale or supply of an MM medicinal product relies on the exemption in regulation 167, the person who sells or supplies the product must maintain a record of the information specified in paragraph (2) from the date that sale or supply first takes place until a date that is at least five years from the date on which supply of the product is discontinued.

• (2) The following information is specified for the purpose of paragraph (1)—

• (a) the source from which, and the date on which, the person obtained the product;

• (b) the person to whom, and the date on which, the sale or supply was made;

• (c) the quantity of the sale or supply;

• (d) the product’s batch number from which the sale or supply was made, or other product identifier if no batch number is available; and

• (e) details of any suspected adverse reaction to the product so sold or supplied of which the person is aware or subsequently becomes aware.

• (3) The person must make the record available for inspection by the licensing authority on request.

• (4) The person must submit electronically to the licensing authority—

• (a) a report on all serious suspected adverse reactions to the product that occur within 15 days of the day following the day on which the person gained knowledge of the reaction, and

• (b) a report on all non-serious suspected adverse reactions to the product that occur in the United Kingdom within 90 days of the day following the day on which the person gained knowledge of the reaction.

• (5) The person must ensure that the reports referred to in paragraph (4)—

• (a) are in the format and have the content specified in Part 6 of Schedule 12A; and

• (b) include the product’s batch number, or other product identifier if no batch number is available.

• (6) The person must, at the written request of the licensing authority, set up a risk management system designed to identify, characterise, prevent or minimise risks relating to the product.

POC medicinal products: pharmacovigilance requirements

170B

• (1) Where the sale or supply of a POC medicinal product relies on the exemption in regulation 167, the person who sells or supplies the product must maintain a record of the information specified in paragraph (2) from the date that sale or supply first takes place until a date that is at least five years from the date on which supply of the product is discontinued.

• (2) The following information is specified for the purpose of paragraph (1)—

• (a) the source from which, and the date on which, the person obtained the product;

• (b) the person to whom, and the date on which, the sale or supply was made;

• (c) the quantity of the sale or supply;

• (d) the product’s batch number from which the sale or supply was made, or other product identifier if no batch number is available; and

• (e) details of any suspected adverse reaction to the product so sold or supplied of which the person is aware or subsequently becomes aware.

• (3) The person must make the record available for inspection by the licensing authority on request.

• (4) The person must submit electronically to the licensing authority—

• (a) a report on all serious suspected adverse reactions to the product that occur within 15 days of the day following the day on which the person gained knowledge of the reaction, and

• (b) a report on all non-serious suspected adverse reactions to the product that occur in the United Kingdom within 90 days of the day following the day on which the person gained knowledge of the reaction.

• (5) The person must ensure that the reports referred to in paragraph (4)—

• (a) are in the format and have the content specified in Part 6 of Schedule 12A; and

• (b) include the product’s batch number, or other product identifier if no batch number is available.

• (6) The person must, at the written request of the licensing authority, set up a risk management system designed to identify, characterise, prevent or minimise risks relating to the product.

Exempt advanced therapy medicinal products

Parallel import licences

Exemption for certain radiopharmaceuticals

Supply in response to spread of pathogenic agents etc

Conditions of temporary authorisations under regulation 174

Packaging requirements: POC medicinal products

257CA

• (1) This regulation applies to a POC medicinal product that is the subject of a UKMA(UK)(Category 1) and not—

• (a) an advanced therapy medicinal product; and

• (b) to be administered in its entirety immediately after manufacture.

• (2) The information specified in Part 6 of Schedule 24 must appear—

• (a) on the outer packaging of a POC medicinal product to which this regulation applies; and

• (b) on the immediate packaging of that product, unless paragraph (3) or (4) applies to the packaging.

• (3) This paragraph applies to the immediate packaging if the packaging is in the form of a blister pack and is placed in outer packaging which complies with the requirements of Part 6 of Schedule 24.

• (4) This paragraph applies to the immediate packaging if the packaging is too small to display the information required by Part 6 of Schedule 24.

• (5) The information specified in Part 7 of Schedule 24 must appear on the immediate packaging to which paragraph (3) or (4) applies.

Guidance as to packaging and package leaflets

Regulation-making power as to certain forms of labelling

Packaging requirements: specific provisions

Packaging requirements: information for blind and partially sighted patients

Package leaflets

Use of pictures and symbols etc

Labelling requirements for radionuclides

Leaflets relating to radionuclides

Homoeopathic medicines

Additional requirements for traditional herbal medicinal products

Language requirements etc

Submission of mock-ups of packaging and leaflets to licensing authority

Manufacturer’s licences (MM)

1A

• (1) This paragraph applies to an application for a manufacturer’s licence relating to MM medicinal products.

• (2) In addition to the requirements in paragraph 1, the application must be accompanied by a dossier for each MM medicinal product to which the application relates, which includes, as a minimum, the following—

• (a) a description and means of identification of each modular unit at which manufacture or assembly of the MM medicinal product is to take place;

• (b) the location of each unit at which manufacturing or assembly of the MM medicinal product is to take place;

• (c) the location of each site at which operations related to the manufacture or assembly of the MM medicinal product are to take place;

• (d) a description of the process by which the licence holder will approve new modular units;

• (e) a description of the processes by which the licence holder will initiate, suspend and cease manufacturing or assembly of the product at a modular unit;

• (f) a description of the manufacturing, assembly and product release processes to take place at each modular unit;

• (g) a description of the arrangements for supervision and control by the licence holder of the manufacture or assembly operations at each modular unit;

• (h) a description of the arrangements for reporting of suspected adverse reactions from modular units to the MM control site;

• (i) the name and contact details of the person at the MM control site who is to be contacted in respect of manufacturing or assembly operations under the licence;

• (j) the name and contact details of the person to be contacted in respect of manufacturing or assembly operations at each modular unit;

• (k) the name and contact details of the person at the MM control site who is to be contacted in respect of quality operations under the licence;

• (l) the name and contact details of the person to be contacted in respect of quality operations at each modular unit; and

• (m) a description of the processes by which the licence holder will review and amend the MM master file for the product.

Manufacturer’s licence (POC)

1B

• (1) This paragraph applies to an application for a manufacturer’s licence relating to POC medicinal products.

• (2) In addition to the requirements in paragraph 1, the application must be accompanied by a dossier for each POC medicinal product to which the application relates, which includes, as a minimum, the following—

• (a) the location of each site at which manufacturing or assembly of the POC medicinal product is to take place;

• (b) the location of each site at which operations related to the manufacture or assembly of the POC medicinal product are to take place;

• (c) a description of the process by which the licence holder will approve new POC sites;

• (d) a description of the processes by which the licence holder will suspend and cease manufacturing or assembly of the POC medicinal product at a POC site;

• (e) a description of the manufacturing, assembly and product release processes to take place at each POC site;

• (f) a description of the arrangements for supervision and control by the licence holder of the manufacture or assembly operations at each POC site;

• (g) a description of the arrangements for reporting of suspected adverse reactions from POC sites to the POC control site;

• (h) the name and contact details of the person at the POC control site who is to be contacted in respect of manufacturing or assembly operations under the licence;

• (i) the name and contact details of the person to be contacted in respect of manufacturing or assembly operations at each POC site;

• (j) the name and contact details of the person at the POC control site who is to be contacted in respect of quality operations under the licence;

• (k) the name and contact details of the person who is to be contacted in respect of quality operations at each POC site; and

• (l) a description of the processes by which the licence holder will review and amend the POC master file for the product.

Part 1A — Manufacturer’s licence (MM)

14C

The provisions of paragraphs 14D to 14K are incorporated as additional standard provisions of a manufacturer’s licence (MM).

14D

The licence holder must maintain an MM master file for each MM medicinal product specified in the licence.

14E

An MM master file may relate to one MM medicinal product only.

14F

An MM master file must contain, as a minimum, the following information—

• (a) the information specified in paragraph 1A(2) of Schedule 3; and

• (b) the location and identification of any modular unit at which manufacturing or assembly of the MM medicinal product has commenced, has been suspended or has ceased, the date on which manufacturing or assembly commenced or ceased, and the dates on which it was suspended.

14G

The licence holder must ensure that the information contained in the MM master file is kept up to date, and consistent with any UK marketing authorisation for the product, at all times.

14H

The licence holder must make the MM master file available to the licensing authority at all times on request.

14I

The licence holder must submit to the licensing authority, at annual intervals, an update of any changes to the MM master file made in the previous 12 month period, the first update being required to be submitted no later than the date that is 12 months from the date on which the manufacturer’s licence (MM) was granted.

14J

The licence holder must keep under review the arrangements for supervision and control of the manufacture or assembly operations at each modular unit and, if the arrangements are found to be inadequate, ensure that appropriate remedial action is taken as soon as reasonably practicable.

14K

• (1) The licence holder must record all suspected adverse reactions to the MM medicinal product which are brought to the licence holder’s attention.

• (2) The licence holder must not refuse to consider reports of suspected adverse reactions to the product received electronically or by any other appropriate means from patients or from health care professionals.

• (3) The licence holder must report suspected adverse reactions identified under sub-paragraph (1) to the holder of the UK marketing authorisation, or the EAMS scientific opinion holder (as applicable), relating to the MM medicinal product as soon as reasonably practicable after the licence holder gains knowledge of the reaction.

Part 1B — Manufacturer’s Licence (POC)

14L

The provisions of paragraphs 14M to 14T are incorporated as additional standard provisions of a manufacturer’s licence (POC).

14M

The licence holder must maintain a POC master file for each POC medicinal product specified in the licence.

14N

A POC master file may relate to one POC medicinal product only.

14O

A POC master file must contain, as a minimum, the following information:

• (a) the information specified in paragraph 1B(2) of Schedule 3; and

• (b) the location of any POC sites at which manufacturing or assembly of the POC medicinal product has commenced, has been suspended or has ceased, the date on which manufacturing or assembly commenced or ceased, and the dates on which it was suspended.

14P

The licence holder must ensure that the information contained in the POC master file is kept up to date, and consistent with any UK marketing authorisation for the product, at all times.

14Q

The licence holder must make the POC master file available to the licensing authority at all times on request.

14R

The licence holder must submit to the licensing authority, at annual intervals, an update of any changes to the POC master file made in the previous 12 month period, the first update being required to be submitted no later than the date that is 12 months from the date on which the manufacturer’s licence (POC) was granted.

14S

The licence holder must keep under review the arrangements for supervision and control of the manufacture or assembly operations at each POC site and, if the arrangements are found to be inadequate, ensure that appropriate remedial action is taken as soon as reasonably practicable.

14T

• (1) The licence holder must record all suspected adverse reactions to the POC medicinal product which are brought to the licence holder’s attention.

• (2) The licence holder must not refuse to consider reports of suspected adverse reactions to the product received electronically or by any other appropriate means from patients or from health care professionals.

• (3) The licence holder must report suspected adverse reactions identified under sub-paragraph (1) to the holder of any UK marketing authorisation, or the EAMS scientific opinion holder (as applicable), relating to the POC medicinal product as soon as reasonably practicable after the licence holder gains knowledge of the reaction.

12B

In the case of an MM medicinal product or a POC medicinal product, the obligations in paragraphs 12(1)(a) and 12A(1)(a) may be satisfied by securing that each product has been manufactured and checked in accordance with these Regulations and the requirements of the marketing authorisation relating to the product.

PART 6 — Outer and Immediate Packaging: POC Medicinal Products for sale or supply in Great Britain only

54

The name of the medicinal product.

55

The strength and pharmaceutical form of the product.

56

Where appropriate, whether the product is intended for babies, children or adults.

57

The expiry date, including the year and month and, if applicable, the day or time in hours and minutes.

58

Where the product contains up to three active substances, the common name of each active substance.

59

A statement of the active substances in the product, expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a given volume or weight, using their common names.

60

The pharmaceutical form and the contents by weight, by volume or by number of doses of the product.

61

A list of—

• (a) where the product is injectable or is a topical or eye preparation, all excipients; or

• (b) in any other case, those excipients known to have a recognised action or effect and included in the guidance published under regulation 257D that is applicable to such products.

62

The method of administration of the product and if necessary the route of administration.

63

Where appropriate, space for the prescribed dose to be indicated.

64

A warning that the product must be stored out of the reach and sight of children.

65

Any special warning applicable to the product.

66

Any special precautions relating to the disposal of an unused product or part of a product, or waste derived from the product, and reference to any appropriate collection system in place.

67

The name and address of the holder of the UK marketing authorisation relating to the product and, where applicable, the name of the holder’s representative.

68

The number of the UK marketing authorisation for placing the product on the market.

69

The manufacturer’s batch number or other product identifier.

70

The patient’s name and unique patient identifier.

PART 7 — Immediate Packaging: Blister Packs and Small Packaging (POC Medicinal Products for sale or supply in Great Britain only)

71

The name of the medicinal product.

72

The strength and pharmaceutical form of the product.

73

Where appropriate, whether the product is intended for babies, children or adults.

74

The expiry date, including the year and month and, if applicable, the day or time in hours and minutes.

75

Where the product contains up to three active substances, the common name of each active substance.

76

The method of administration of the product and if necessary the route of administration.

77

The name of the holder of the UK marketing authorisation relating to the product.

78

The manufacturer’s batch number or other product identifier.

79

The contents of the packaging by weight, by volume or by unit.

80

The patient’s name and unique patient identifier.

Assembly or part-assembly as part of “hub and spoke” dispensing arrangements between different businesses

222A

• (1) Paragraph (2) applies where—

• (a) an order for the sale or supply of a medicinal product to or for the use of a particular patient (P) is submitted to a person acting in the course of a retail pharmacy business or an NHS dispensing practice;

• (b) the person carrying on the retail pharmacy business or the NHS dispensing practice (B1) has entered into written arrangements (whether or not legally binding) with a person carrying on a retail pharmacy business (B2) which—

• (i) are for the purpose of B2 supporting B1 with regard to the fulfilment of orders submitted as mentioned in sub-paragraph (a) (but must not allow B2 to fulfil the order directly), and

• (ii) include (but are not limited to) a comprehensive statement of the responsibilities of B1 and B2 in relation to those orders;

• (c) B1 has conspicuously displayed a notice—

• (i) at B1’s registered pharmacy or premises of B1’s NHS dispensing practice, if B1 supplies medicinal products to patients who are present at that pharmacy or those premises, and

• (ii) in B1’s dispensing content for patients, if B1 sells or supplies medicinal products by means of an internet service,

containing the names and addresses of any parties with whom they have entered into arrangements of the type mentioned in sub-paragraph (b) and a brief statement of the general effect of the arrangements;

• (d) the medicinal product is—

• (i) assembled or part-assembled in the course of B2’s business, and

• (ii) sold or supplied by B2 to B1,

as part of the written arrangements of the type mentioned in sub-paragraph (b); and

• (e) the activities carried out as mentioned in sub-paragraph (d) are carried out with a view to any of the following taking place at or from premises of B1 (following further assembly in the case of part-assembled products)—

• (i) the retail sale of the product by B1 to or for the use of P, or

• (ii) the supply of the product in circumstances corresponding to retail sale by B1 to or for the use of P.

• (2) For the purposes of these Regulations and the Medicines Act 1968, each sale or supply mentioned in paragraph (1)(d)(ii) by B2—

• (a) is treated as or as part of a retail sale; and

• (b) is treated as being in accordance with a prescription if—

• (i) it is for the purpose of fulfilling an order that is a prescription, and

• (ii) the final sale or supply is in accordance with the prescription,

notwithstanding that B2 does not have the prescription.

• (3) The definitions of “sell” and “supply” in regulation 213(1) do not apply for the purposes of this regulation.

• (4) Where both B1 and B2 are retail pharmacy businesses and a pharmacist may, pursuant to regulation 217B, 217BA or 226A, change an order for the sale or supply of a medicinal product, the final decision as regards whether or not that change is to be made for the sale or supply to or for the use of P is for a pharmacist acting on behalf of B1, even if—

• (a) an initial decision, in accordance with which a retail sale was made by B2 to B1, was made by a pharmacist acting on behalf of B2; and

• (b) the final decision by the pharmacist acting on behalf of B1 is by way of a confirmation of what the pharmacist acting on behalf of B2 initially decided.

Hub and spoke arrangements: sharing of data between different businesses

222B

• (1) For the purposes of section 8(c) (lawfulness of processing: public interest etc) of, and paragraph 2(2)(a), (c) and (d) of Schedule 1 (special categories of personal data etc) to, the Data Protection Act 2018, paragraph (2) applies to the processing of any data—

• (a) by B1 or B2 (as defined in regulation 222A(1)(b)) which relates to a patient; and

• (b) which is necessary for the purposes of—

• (i) fulfilling an order submitted as mentioned in regulation 222A(1)(a) under the written arrangements between B1 and B2 of the type mentioned in regulation 222A(1)(b), or

• (ii) discharging any related professional obligations to the patient (including obligations relating to the keeping of records).

• (2) That processing is—

• (a) necessary for the performance of a task carried out in the public interest; and

• (b) if the data is personal data concerning health, necessary for the purposes of preventative medicine, medical diagnosis or for the provision of health care or treatment.

• (3) Any person (P) who—

• (a) is employed or engaged by B1 or B2; and

• (b) in the course of being so employed or engaged is required to undertake the processing of data described in paragraph (1),

owes a duty of confidentiality in respect of that data (whether or not they would do so but for this paragraph).

• (4) That duty—

• (a) is a duty of confidentiality which, if not owed by a health care professional, is owed under an enactment or rule of law for the purposes of section 11(1)(b) of the Data Protection Act 2018 (special categories of personal data etc: supplementary); and

• (b) is such that, if the processing is necessary for the purposes described in paragraph (1)(b), P is able, lawfully, to process that data by virtue of this regulation.

• (5) For the purposes of paragraph (1)(b)(ii), a professional obligation to a patient is to be regarded as such notwithstanding that discharging the obligation may—

• (a) also be an obligation that arises in some other way (for example, arising from a term of service that is part of NHS pharmaceutical services); or

• (b) be done by a person who is not a health care professional.

• (6) Paragraphs (1) and (2) do not apply where, in reliance or purported reliance on arrangements of the type mentioned in regulation 222A(1)(b), a person processes any data which relates to a patient but, in the course of the doing of anything that relates to the fulfilling of the order to which that data relates, there is a breach of—

• (a) the requirements to be fulfilled if what is done is to be treated as or as part of a retail sale in accordance with regulation 222A(2)(a); or

• (b) a duty of confidentiality owed in respect of the data by a health care professional or under an enactment or rule of law as mentioned in paragraph (4)(a).

• (7) Words and expressions used in both—

• (a) paragraphs (1) to (6); and

• (b) Parts 1 and 2 (preliminary and general processing) of, and paragraphs 2(2)(a), (c) and (d) of Schedule 1 to, the Data Protection Act 2018,

bear the meanings they bear in those provisions of the Data Protection Act 2018.

6A

Where a product is to be sold or supplied in accordance with an order submitted as mentioned in regulation 222A(1)(a), for the purposes of—

• (a) paragraph 2, B1, as defined in regulation 222A(1)(b), is the person who sells or supplies the product;

• (b) paragraph 3, the date is instead the date on which the product is ready for sale or supply to or for the patient for whom it is dispensed; and

• (c) paragraphs 4 to 6, the final form of the particulars to be included for the final sale or supply to or for the use of a patient is to be determined by a pharmacist acting on behalf of B1, even if—

• (i) the inclusion of the particulars was done by or under the supervision of a pharmacist acting on behalf of B2, as defined in regulation 222A(1)(b), and

• (ii) the determination by the pharmacist acting on behalf of B1 is by way of a confirmation of what was done by or under the supervision of a pharmacist acting on behalf of B2.

4A

Where a product is to be sold or supplied in accordance with an order submitted as mentioned in regulation 222A(1)(a), for the purposes of—

• (a) paragraph 2, B1, as defined in regulation 222A(1)(b), is the person who sells or supplies the product; and

• (b) paragraph 3, the date is instead the date on which the product is ready for sale or supply to or for the patient for whom it is dispensed.

10A

Where a product is to be sold or supplied in accordance with an order submitted as mentioned in regulation 222A(1)(a), for the purposes of—

• (a) paragraph 6, B1, as defined in regulation 222A(1)(b), is the person who sells or supplies the product;

• (b) paragraph 7, the date is instead the date on which the product is ready for sale or supply to or for the patient for whom it is dispensed; and

• (c) paragraphs 8 to 10, the final form of the particulars to be included for the final sale or supply to or for the use of a patient is to be determined by a pharmacist acting on behalf of B1, even if—

• (i) the inclusion of the particulars was done by or under the supervision of a pharmacist acting on behalf of B2, as defined in regulation 222A(1)(b), and

• (ii) the determination by the pharmacist acting on behalf of B1 is by way of a confirmation of what was done by or under the supervision of a pharmacist acting on behalf of B2.

Sale or supply of items dispensed by a pharmacist who is absent or treated as absent

220B

• (1) A person (P1) acts in accordance with this regulation where—

• (a) the transaction relates to a medicinal product that has been dispensed by or under the supervision of a pharmacist (P2) and is ready for sale or supply to or for the person for whom it has been dispensed;

• (b) P2 authorises P1 to carry out the transaction in question on P2’s behalf in P2’s absence; and

• (c) P1 carries out that transaction on P2’s behalf—

• (i) in P2’s absence, or

• (ii) in circumstances where P2 is treated as being absent,

in accordance with any conditions or restrictions that P2 has imposed pursuant to paragraph (2), sub-paragraphs (b) or (c) (and the authorisation has not been withdrawn).

• (2) An authorisation given for the purposes of paragraph (1)(b)—

• (a) may be given orally or in writing;

• (b) may be given subject to conditions or restrictions; and

• (c) may be varied or withdrawn by P2.

• (3) In giving an authorisation for the purposes of paragraph (1)(b), P2 must have due regard to patient safety.

• (4) A failure to comply with paragraph (3)—

• (a) does not affect the validity of any authorisation, but

• (b) may constitute misconduct for the purposes of section 80 of the Medicines Act 1968 (power for relevant disciplinary committee to disqualify and direct removal from register) or article 51(1)(a) of the Pharmacy Order 2010 (impairment of fitness to practise) and the relevant disciplinary committee may deal with any such failure accordingly.

• (5) For the purposes of paragraph (1)(c)(ii), P2 is to be treated as being absent from premises that are a registered pharmacy if P2 is at the pharmacy but not available to intervene in, or not in a position to intervene in, the transaction in question.

Sale or supply of medicinal products subject to general sale

Sale of medicinal products from automatic machines

Assembly or part-assembly as part of “hub and spoke” dispensing arrangements between different businesses

Hub and spoke arrangements: sharing of data between different businesses

Exemption for supply or administration of certain medicines used for vaccination

235A

• (1) Regulations 214, 220 and 221 do not apply to the supply or administration of a medicinal product used for vaccination in accordance with conditions A to F by—

• (a) a public health agency;

• (b) a health authority or special health authority;

• (c) an NHS Trust;

• (d) an NHS Foundation Trust;

• (e) a local authority in the exercise of public health functions (within the meaning of the National Health Service Act 2006); or

• (f) a person under relevant arrangements.

• (2) Condition A is that the medicinal product is used for vaccination—

• (a) for the purpose of providing protection against an infectious disease; and

• (b) as part of a vaccination programme that has been approved by the Secretary of State, the Scottish Ministers, the Welsh Ministers or the Minister of Health in Northern Ireland.

• (3) Condition B is that the medicinal product is supplied for the purpose of being administered to a person in accordance with the requirements of a vaccine group direction which has been produced by a public health agency.

• (4) Condition C is that the vaccine group direction—

• (a) is signed by or on behalf of—

• (i) in the case of supply or administration by a body listed in paragraph (1)(a) to (e), a senior manager of that body, or

• (ii) in the case of supply or administration by a person as mentioned in paragraph (1)(f), a senior manager of the body that enters into the relevant arrangements with that person; and

• (b) has effect at the time at which the medicinal product is administered.

• (5) Condition D is that the individual who administers the medicinal product is either at the same location and under the supervision of an individual who, or is an individual who—

• (a) has—

• (i) assessed and determined that the person who is to receive the medicinal product is eligible for the treatment, and

• (ii) obtained and recorded the informed consent of, or in respect of, the person who is to receive the medicinal product; and

• (b) belongs to one of the classes of individuals specified in Part 4 of Schedule 16.

• (6) Condition E is that the vaccine group direction contains the particulars specified in Part 1 of Schedule 16, and specifies—

• (a) the classes of persons permitted to administer medicinal products under the direction;

• (b) the process by which a person of a specified class is designated, and by whom, as a person permitted to administer medicinal products under the direction; and

• (c) requirements, where appropriate, for the supervision of a person who, on any particular occasion, administers a medicinal product under the direction.

• (7) Condition F is that, when the medicinal product is administered, there is in force in relation to it—

• (a) a UK marketing authorisation; or

• (b) an authorisation by the licensing authority on a temporary basis under regulation 174.

• (8) In this regulation—

• “a public health agency” means—Public Health Scotland in respect of Scotland;Public Health Wales in respect of Wales;the UK Health Security Agency in respect of England;the Public Health Agency in respect of Northern Ireland;

• “relevant arrangements” has the meaning given in regulation 19(4C) (exemptions from requirement for wholesale dealer’s licence);

• “senior manager” means a person who plays a significant role (irrespective of whether other individuals also do so) in—the making of decisions about how the whole or a substantial part of the activities of the body in question are to be managed or organised, orthe actual managing or organising of the whole or a substantial part of those activities.