The Veterinary Medicines Regulations 2008

Regulation 5(2)

SCHEDULE 2 The manufacture of veterinary medicinal products

1. PART 1 Manufacturing authorisations

   1. 1. Application

   2. 2. Time limits

   3. 3. Granting the authorisation

   4. 4. The authorisation

   5. 5. Suspension, variation or revocation of the authorisation

   6. 6. Inspection of premises

   7. 7. Report following inspection

   8. 8. Duties on the holder of a manufacturing authorisation

   9. 9. Qualified persons for manufacture

   10. 10. Refusal or revocation of appointment

   11. 11. Duties on a qualified person

   12. 12. Register

   13. 13. Test sites

2. PART 2 Authorisation of manufacturers of autogenous vaccines

   1. 14. Authorisation to manufacture autogenous vaccines

   2. 15. Types of authorisation

   3. 16. Labelling

   4. 17. Records

   5. 18. Adverse reactions

   6. 19. Inspection of premises

3. PART 3 Authorisation of blood banks

   1. 20. Authorisation of blood banks

   2. 21. Supply and administration of blood from a blood bank

   3. 22. Labelling

   4. 23. Records

   5. 24. Inspection of blood banks

4. PART 4 Authorisation of manufacturers of products for administration under the cascade

   1. 25. Authorisation to manufacture products for administration under the cascade

   2. 26. Labelling

   3. 27. Records

   4. 28. Adverse reactions

   5. 29. Inspection of premises

5. PART 5 Authorisation of equine stem cell centres

   1. 30. Authorisation of stem cell centres

   2. 31. Supply and administration of stem cells

   3. 32. Labelling

   4. 33. Records

   5. 34. Inspection of equine stem cell centres

PART 1 Manufacturing authorisations

Application

1.  An application for a manufacturing authorisation must be made to the Secretary of State.

Time limits

2.—(1) The Secretary of State must process an application for a manufacturing authorisation within 90 days of receiving it.

(2) The Secretary of State must process an application for a variation of a manufacturing authorisation within 30 days unless the Secretary of State notifies the applicant in writing that the time has been extended to 90 days.

Granting the authorisation

3.  The Secretary of State must grant a manufacturing authorisation on being satisfied that the applicant has suitable and sufficient premises, staff, technical equipment and facilities for the manufacture, control and storage of the products, and will comply with these Regulations.

The authorisation

4.—(1) The manufacturing authorisation must specify—

(a) the types of veterinary medicinal products and pharmaceutical forms that may be manufactured or imported;

(b) the place where they are to be manufactured or controlled;

(c) the name and address of the person holding the authorisation;

(d) the address of the premises to which it relates;

(e) the name of all qualified persons nominated to act under this Schedule.

(2) It may specify that different activities must be carried out in different premises or parts of premises, and may require the holder of the manufacturing authorisation to restrict access to premises or parts of premises to persons carrying out activities there.

(3) The holder of a manufacturing authorisation must notify the Secretary of State, and if necessary apply for a variation of the authorisation, before making a material alteration to the premises or facilities used under the authorisation, or to the operations for which they are used, and failure to do so is an offence.

Suspension, variation or revocation of the authorisation

5.—(1) The Secretary of State may suspend, vary or revoke a manufacturing authorisation if the holder—

(a) has not complied with these Regulations;

(b) has manufactured a veterinary medicinal product not authorised by the manufacturing authorisation;

(c) has produced a veterinary medicinal product outside the terms of a marketing authorisation; or

(d) no longer has suitable premises or equipment.

(2) The Secretary of State may also suspend, vary or revoke it on being satisfied that the qualified person (manufacture) is not fulfilling their duties under these Regulations.

Inspection of premises

6.—(1) The Secretary of State must inspect the premises relating to a manufacturing authorisation on a regular basis to ensure compliance with good manufacturing practice.

(2) Within 90 days after an inspection, the Secretary of State must issue a certificate of good manufacturing practice to the manufacturer if the inspection established compliance with the principles and guidelines on good manufacturing practice in accordance with Commission Directive 91/412/EEC laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products(1).

(3) If an inspection is carried out at the request of the European Pharmacopoeia to establish compliance with a monograph, the Secretary of State must issue a certificate of compliance with the monograph, if appropriate.

(4) The Secretary of State must provide details of each certificate of good manufacturing practice issued to the Agency for entry into a database.

(5) If the outcome of the inspection is that the manufacturer does not comply with the principles and guidelines of good manufacturing practice, the Secretary of State must provide details to the Agency for entry into the database.

Report following inspection

7.—(1) After each inspection of manufacturing premises, the inspector must make a written report to the Secretary of State on whether the principles and guidelines on good manufacturing practice and the conditions of these Regulations are being complied with.

(2) The Secretary of State must inform the inspected manufacturer of the content of such reports.

Duties on the holder of a manufacturing authorisation

8.—(1) A holder of a manufacturing authorisation must ensure that the veterinary medicinal product is manufactured in accordance with the marketing authorisation.

(2) The holder must have permanently at their disposal the services of at least one qualified person (manufacture) who is on the register of qualified persons (manufacture) maintained by the Secretary of State.

(3) The holder must—

(a) have a current Certificate of Good Manufacturing Practice;

(b) have in place a system of Quality Assurance and Quality Control; and

(c) give to the Secretary of State on request proof of all control tests carried out on the veterinary medicinal product or the constituents and intermediate products of the manufacturing process in accordance with the data submitted in support of the application for the marketing authorisation.

(4) A holder who makes up a bulk package of veterinary medicinal products must ensure that the package is labelled, in a way that the label is clearly visible and legible, with—

(a) the name of the veterinary medicinal product, its strength as shown in the summary of product characteristics and its pharmaceutical form;

(b) the batch number;

(c) the expiry date;

(d) any storage requirements; and

(e) any other warning necessary for the safe handling of the package.

(5) A holder must keep an adequate number of representative samples of each batch of a veterinary medicinal product in stock at least until the expiry date of the batch, and must submit any such sample to the Secretary of State if required in writing to do so.

Qualified persons for manufacture

9.—(1) The Secretary of State may appoint as a qualified person (manufacture) any person who is—

(a) registered as a pharmaceutical chemist with the Royal Pharmaceutical Society of Great Britain or with the Pharmaceutical Society of Northern Ireland;

(b) a Chartered Chemist or a Fellow, Member or Associate Member of the Royal Society of Chemistry; or

(c) a Chartered Biologist or a Fellow, Member or Associate Member of the Institute of Biology,

who qualified on the basis of a formal course of study lasting not less than three years full-time or equivalent and who has sufficient practical experience to carry out the duties under this Schedule.

(2) The Secretary of State may exceptionally appoint a person who is not a member of one of those institutions to act as a qualified person (manufacture) on being satisfied that that person has the educational qualifications or practical experience to carry out the duties under this Schedule.

Refusal or revocation of appointment

10.  The Secretary of State may refuse or revoke an appointment if the Secretary of State is not satisfied that a person has fulfilled or will fulfil duties under these Regulations.

Duties on a qualified person

11.—(1) The qualified person (manufacture) must ensure that each batch of veterinary medicinal product manufactured under that person’s responsibility is manufactured and checked in compliance with these Regulations and in accordance with the data submitted in support of the application for the marketing authorisation.

(2) If a manufacturer imports a veterinary medicinal product from a third country, including a product manufactured in a member State, the qualified person (manufacture) must ensure that, following importation, each production batch imported is fully tested in a member State, including a full qualitative analysis, a quantitative analysis of at least all the active substances and all the other tests or controls necessary to ensure the quality of a veterinary medicinal product is in accordance with the requirements of the marketing authorisation.

(3) The preceding paragraph does not apply where appropriate arrangements have been made by the European Community with the exporting country to ensure that the manufacturer of the veterinary medicinal product applies standards of good manufacturing practice at least equivalent to those laid down in Commission Directive 91/412/EEC and to ensure that the controls in sub‑paragraph (2) have been carried out in the exporting country.

(4) At each stage of manufacture, including release for sale, the qualified person (manufacture) must certify in writing that all control tests required under the marketing authorisation have been carried out, and that the production batch complies with the marketing authorisation.

(5) It is an offence to fail to comply with this paragraph.

Register

12.  The Secretary of State must maintain and publish a register of holders of manufacturing authorisations and qualified persons (manufacture).

Test sites

13.—(1) The Secretary of State may authorise premises to act as a test site to carry out contract testing for a holder of a manufacturing authorisation.

(2) The premises must have a current certificate of good manufacturing practice.

(3) Authorisation and inspection of the premises are the same as for a manufacturing authorisation.

PART 2 Authorisation of manufacturers of autogenous vaccines

Authorisation to manufacture autogenous vaccines

14.—(1) The Secretary of State may authorise a person and premises to manufacture autogenous vaccines.

(2) In order to be authorised the premises must be under the supervision of—

(a) a veterinary surgeon, or

(b) a person who the Secretary of State is satisfied has sufficient qualifications and experience to manufacture the product safely.

(3) Before authorising the premises, the Secretary of State must be satisfied that the production process will produce a consistent, safe product.

(4) It is an offence to manufacture an autogenous vaccine other than in accordance with such an authorisation.

Types of authorisation

15.—(1) The authorisation must specify the products that may be manufactured.

(2) It may either be for the production of a single batch of product or for on-going production of the products specified in the authorisation.

(3) If it is for a single batch it must be time-limited.

(4) Only the products specified in the authorisation may be manufactured, and in the case of an authorisation for a single batch the product may only be manufactured before the expiry of the authorisation.

Labelling

16.—(1) The operator of the premises must ensure that every container containing autogenous vaccine is labelled with—

(a) the name of the veterinary surgeon who ordered the vaccine;

(b) a precise description of the vaccine;

(c) the date the vaccine was produced;

(d) the name of the authorisation holder and address of the authorised premises;

(e) the expiry date;

(f) any necessary warnings; and

(g) instructions for use.

(2) It is an offence to fail to comply with this paragraph.

Records

17.—(1) The operator of the premises must, as soon as is reasonably practicable record—

(a) the name and address of the veterinary surgeon who ordered the vaccine;

(b) the identification of the source animal;

(c) the expiry date;

(d) the date of supply to the veterinary surgeon,

and must keep the records for at least five years.

(2) It is an offence to fail to comply with this paragraph.

Adverse reactions

18.—(1) The authorised person must notify the Secretary of State of any adverse reactions to an autogenous vaccine within 15 days of learning of the reaction.

(2) It is an offence to fail to comply with this paragraph.

Inspection of premises

19.  The Secretary of State must inspect the authorised premises every two years.

PART 3 Authorisation of blood banks

Authorisation of blood banks

20.—(1) The Secretary of State may authorise blood banks for—

(a) the collection, storage and supply of blood, or

(b) the storage and supply of blood constituents obtained by the physical separation of donor blood into different fractions within a closed-bag system,

for the treatment of non-food-producing animals.

(2) The authorisation may be for either or both of these activities.

(3) In order to be authorised a blood bank must be under the supervision of—

(a) a veterinary surgeon named in the authorisation; or

(b) a person named in the authorisation who the Secretary of State is satisfied is suitably qualified to operate the blood bank.

(4) Before authorising a blood bank, the Secretary of State must be satisfied—

(a) that the welfare of animals used in the collection of blood will be respected; and

(b) that the production process will produce a consistent, safe product.

(5) The procedure for the suspension or revocation of the authorisation is the same as for the holder of a manufacturing authorisation.

(6) Blood may only be collected under the responsibility of a veterinary surgeon.

(7) It is an offence to operate a blood bank for treatment of animals other than in accordance with such an authorisation.

Supply and administration of blood from a blood bank

21.—(1) The blood may only be supplied to a veterinary surgeon.

(2) It may only be administered by a veterinary surgeon or under a veterinary surgeon’s responsibility.

(3) It may only be administered to non-food-producing animals.

(4) It is an offence to fail to comply with this paragraph.

Labelling

22.—(1) The operator of a blood bank must ensure that every container used for the blood is labelled with—

(a) the identification of the donor animal;

(b) the date of collection;

(c) the authorisation number of the blood bank;

(d) any necessary warnings;

(e) the expiry date.

(2) There must be no specific therapeutic indication on the label or on any information relating to the product.

(3) It is an offence to fail to comply with this paragraph.

Records

23.—(1) The operator of a blood bank must, as soon as is reasonably practicable, record—

(a) the date of collection;

(b) the identification of the donor animal;

(c) the veterinary surgeon who collected it;

(d) the expiry date;

(e) the date the blood was used or, if it was supplied to another veterinary surgeon, the name of that veterinary surgeon and the date it was supplied,

and must keep the records for at least five years.

(2) It is an offence to fail to comply with this paragraph.

Inspection of blood banks

24.  The Secretary of State must inspect a blood bank every two years.

PART 4 Authorisation of manufacturers of products for administration under the cascade

Authorisation to manufacture products for administration under the cascade

25.—(1) The Secretary of State may authorise a person and premises to manufacture an unauthorised veterinary medicinal product for administration under the cascade.

(2) In order to be authorised the premises must be under the supervision of a person who the Secretary of State is satisfied has sufficient qualifications and experience to manufacture the product safely.

(3) Before authorising the premises, the Secretary of State must be satisfied that the production process will produce a safe product.

(4) The procedure for the suspension or revocation of the authorisation is the same as for the holder of a manufacturing authorisation.

(5) The authorisation must specify what types of product it covers.

(6) It is an offence for the holder of an authorisation to manufacture a product other than in accordance with the authorisation.

Labelling

26.—(1) The authorised person must ensure that, before a veterinary medicinal product is supplied, every container is labelled with—

(a) the name of the veterinary surgeon who ordered the veterinary medicinal product;

(b) a precise description of the veterinary medicinal product;

(c) the date of production;

(d) the name of the authorisation holder and the address of the authorised premises;

(e) the expiry date;

(f) any necessary warnings; and

(g) instructions for use.

(2) It is an offence to fail to comply with this paragraph.

Records

27.—(1) The authorised person must, as soon as is reasonably practicable, record—

(a) the name and address of the veterinary surgeon who ordered the veterinary medicinal product;

(b) a precise description of the veterinary medicinal product;

(c) the date of production;

(d) the expiry date; and

(e) the date of supply to the veterinary surgeon,

and must keep the record for at least five years.

(2) It is an offence to fail to comply with this paragraph.

Adverse reactions

28.—(1) The authorised person must notify the Secretary of State of any adverse reactions to a product manufactured by that person within 15 days of learning of the reaction.

(2) It is an offence to fail to comply with this paragraph.

Inspection of premises

29.  The Secretary of State must inspect the authorised premises every two years.

PART 5 Authorisation of equine stem cell centres

Authorisation of stem cell centres

30.—(1) The Secretary of State may authorise equine stem cell centres for the collection, storage, processing, production and administration of equine stem cells for use as an autologous treatment for horses.

(2) In order to be authorised a centre must be under the supervision of—

(a) a veterinary surgeon named in the authorisation; or

(b) a person named in the authorisation who the Secretary of State is satisfied is suitably qualified to operate the centre.

(3) Before authorising a centre, the Secretary of State must be satisfied—

(a) that the welfare of animals used in the collection of equine stem cells will be respected; and

(b) that the production process will produce a consistent, safe product.

(4) Equine stem cells may only be collected under the responsibility of a veterinary surgeon.

(5) It is an offence to operate an equine stem cell centre other than in accordance with such an authorisation.

Supply and administration of stem cells

31.—(1) Only equine stem cells may be collected.

(2) They may not be collected from embryonic tissues.

(3) The product grown from the collected equine stem cell may only be administered by a veterinary surgeon or under a veterinary surgeon’s responsibility.

(4) It may only be administered to non-food-producing horses.

(5) It is an offence to fail to comply with this paragraph.

Labelling

32.—(1) The operator of an equine stem cell centre must ensure that every container used for the stem cell product is labelled with—

(a) the identification of the donor animal;

(b) the date of collection;

(c) the authorisation number of the equine stem cell centre;

(d) any necessary warnings;

(e) the expiry date.

(2) There must be no specific therapeutic indication on the label or on any information relating to the product.

(3) It is an offence to fail to comply with this paragraph.

Records

33.—(1) The operator of an equine stem cell centre must, as soon as is reasonably practicable, record for each stem cell product—

(a) the identification of the donor animal;

(b) the date of collection;

(c) the veterinary surgeon under whose responsibility the stem cells were collected;

(d) the expiry date;

(e) the date the product was used or, if it was supplied to another veterinary surgeon, the name of that veterinary surgeon and the date it was supplied,

and must keep the records for at least five years.

(2) It is an offence to fail to comply with this paragraph.

Inspection of equine stem cell centres

34.  The Secretary of State must inspect the authorised premises every two years.

(1)

OJ No. L 228, 17.8.91, p. 70.