GovWire

You need an authorisation to manufacture:

• an authorised veterinary medicine
• a medicine marketed under Schedule 6 of the Veterinary Medicines Regulations (Exemptions for small pet animals)

If you require an authorisation to manufacture:

• an extemporaneous preparation for administration to an animal under the prescribing cascade (also known as a special)
• a veterinary autogenous vaccine
• a stem cell product or blood product for administration to non-food animals

go to Specific Manufacturing Authorisations.

Manufacturers of human and veterinary medicines

If you manufacture human medicines and want to additionally manufacture veterinary medicines, you should refer to guidance published by theMedicines and Healthcare products Regulatory Agency (MHRA). The MHRA publishes a public register of these sites.

Authorisation to manufacture an authorised veterinary medicine (ManA)

You must hold amanufacturing authorisation (ManA) to carry out any of the following activities in relation to an authorised veterinary medicine:

• the manufacture of a veterinary medicine whether for use in Great Britain or another country
• the carrying out of any part of the manufacturing process in bringing a veterinary medicine to its final state including; processing, assembling, packaging or repackaging, labelling or relabelling, storing, sterilising or releasing for supply of a veterinary medicine
• the importation of any veterinary medicine for use in Great Britain, other than in accordance with the cascade

You do not need aManAto:

• prepare, divide up, change the packaging or presentation of a veterinary medicine where this is done solely for retail supply, by or under the supervision of a veterinary surgeon or pharmacist in a registered veterinary practice premises or pharmacy. A pharmacist may not break the immediate packaging of sterile products
• manufacture a veterinary medicine based on radio-active isotopes
• manufacture a veterinary medicine for administration for research purposes in accordance with an Animal Test Certificate (ATC) or a licence issued under the Animals (Scientific Procedures) Act (A(SP)A) 1986

Your manufacturing site and its operations will be inspected for compliance with the Veterinary Medicines Regulations (VMR) and current good manufacturing practice (GMP).

Duties onManAholders

You must comply, where appropriate to the manufacturing steps performed, with the following requirements relating to your authorisation:

• manufacture the veterinary medicine in accordance with its marketing authorisation (MA)
• have permanently at your disposal the services of at least one Qualified Person (QP) and ensure that all necessary documents, premises and technical and other facilities are placed at that persons disposal to enable them to discharge their duties
• have permanently at your disposal the services of a Production Manager (PM) and a person responsible for quality control (QC Manager)
• comply with current GMP and process a GMPcertificate issued by a UK national competent authority
• ensure that you have quality assurance (QA) and quality control (QC) systems in place
• ensure that the finished product is labelled with:
  • its name, strength and pharmaceutical form
  • its batch number
  • its expiry date
  • its storage requirements
  • any warnings required for safe handling of the product
• ensure that you retain a representative sample of the finished product and make it available to us for testing, if requested
• ensure each batch of product manufactured or imported is batch (QC) tested to confirm that it meets its required specification before being certified/released to the market by the QP. The QP may accept batch testing carried out in a country with which the UK has a mutual recognition agreement see batch certification below
• inform us and the marketing authorisation holder, if applicable, where you obtain information that a veterinary medicine that falls within the scope of your authorisation is falsified, or is suspected of being falsified, irrespective of whether the product was distributed within the legal supply chain or by illegal means
• keep detailed records of each batch of veterinary medicine you manufacture or import, as required by GMP, and all certification provided by the QP in relation to that batch
• keep the following details of all veterinary medicines you supply:
  • the name of the veterinary medicine and its marketing authorisation number if applicable
  • the pharmaceutical form and strength of the product
  • the quantity of product supplied
  • the batch number and expiry date
  • the date of the transaction on which the product was supplied
  • the company name and the permanent address or registered place of business of the recipient.

Good Manufacturing Practice (GMP)

GMPis defined as the part of quality assurance which ensures that products are consistently produced and controlled in accordance with the quality standards appropriate to their intended use and as required by the applicable marketing authorisation or product specification.

You must manufacture veterinary medicines in accordance with GMP, which includes:

• conducting the manufacturing operations in accordance with a pharmaceutical quality system (PQS), which must be:
  • clear
  • systematically reviewed from time to time in the light of experience
  • capable of consistently manufacturing veterinary medicines which are of the required quality and which meet the requirements of the relevant marketing authorisation.
• the critical steps of the manufacturing process set out in the PQS must be validated
• any significant amendments to the manufacturing process must be validated
• the PQS must provide for:
  • appropriately qualified and trained personnel
  • adequate premises and space
  • suitable equipment and access to services
  • suitable materials, containers and labelling
  • relevant procedures and instructions
  • suitable storage and transport
  • investigation into complaints and defects
  • any significant deviations from its provisions to be fully recorded and investigated, with appropriate corrective and preventative action implemented
• ensuring that you keep records of your manufacturing process, including distribution, in a comprehensible and accessible form for five years after the date on which you place the veterinary medicine on the market or for one year after the expiry date of the batch of veterinary medicine, whichever is the longest

Detailed principles and guidelines forGMPare included inEudralex volume 4.

Requirements for active substances used as starting materials

You may only use as starting materials active substances, also known as active pharmaceutical ingredients or APIs, that have been manufactured in accordance withEudralex Volume 4, Part II. and distributed in accordance with good distribution practice for active substances.

You must verify that each manufacturer, importer or distributor in Great Britain from whom you obtain active substances is appropriately registered and carry out risk-based audits on those suppliers.

If you are the manufacturer of the final dosage form, you must evaluate the suitability of all of your active substance suppliers, wherever they are located, for example by:

• supplier audit, and
• provision of aQPdeclaration concerning GMP compliance of the active substance manufacture

For further information about manufacture, importation and distribution of active substances refer to Apply to register as a manufacturer, importer or distributor of active substances for veterinary medicines.

Transmissible Spongiform Encephalopathy (TSE)

You must comply with the guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via veterinary medicinal products.

Required Personnel

You must appoint the following personnel

Qualified Person (QP)

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