Manufacturing Authorisation (ManA)
You must obtain a ManA if you carry out any of the following manufacturing or assembling activities for an authorised veterinary medicine:
- any process carried out in the course of making the medicine except for dissolving or dispersing the product in, or diluting or mixing it with some other substance used as a vehicle for the purpose of administering it
- enclosing the medicine in a container which is labelled before it is sold or supplied (primary packing)
- labelling the container (where the medicine is already enclosed in the container in which it is to be sold or supplied ie secondary packing) before the medicine is sold or supplied; this includes the over-labelling of medicines
- importing veterinary medicine from a non-EU or European Economic Area (EEA) country and subsequently releasing the medicine to the market (batch certification)
You do not need a ManA to:
- 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 (except 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
Duties of the ManA holder
You must comply (where appropriate to the manufacturing steps performed) with the following legal requirements relating to the manufacture and assembly of veterinary medicines:
- manufacture the veterinary medicine in accordance with its Marketing Authorisation (MA)
- ensure the services of a registered Qualified Person (QP(s) are continuously available
- possess a current EU GMP certificate and ensure the veterinary medicine is produced in accordance with GMP
- ensure Quality Assurance (QA) and Quality Control (QC) systems are in place
- make evidence of any control testing performed in accordance with the product’s MA available to the VMD, on request
- ensure the finished product is labelled with:
- registered name, strength and pharmaceutical form
- batch number
- expiry date
- storage requirements
- any warnings required for safe handling of the product
- ensure a representative sample of the finished product is retained and made available for testing upon request by the VMD.
Compliance with GMP
GMP is 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.
The principles and guidelines for GMP are defined in Eudralex volume 4.
GMP requirements for active substances as starting materials
The active substance (also known as the Active Pharmaceutical Ingredient or API) must have been manufactured in accordance with Eudralex Volume 4, Part II. However, the following materials are exempted from the full application of Part II:
- ectoparasiticidal active substances for veterinary use
- substances that are used exclusively for topical application to the unbroken skin of animals and which are ectoparasiticidal, anti-bacterial or anti-fungal agents
You may only use API from suppliers registered on the MA to manufacture the veterinary medicine.
The suitability of an API supplier must be evaluated by the ManA holder prior to use. This is usually obtained by:
- supplier audit, and
- provision of a QP statement certificate of GMP
Transmissible Spongiform Encephalopathy (TSE)
The ManA holder must comply with the European Commission document EMEA/410/01–Rev 2 Notes for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via veterinary medicinal products.
A ManA holder must appoint the following personnel:
Qualified Person (QP)
At least one QP must be named on the authorisation. The QP must be available on a continuous basis and live in the EEA. The QP’s role and responsibility is defined in Eudralex Volume 4, Chapter 2 and Annex 16.
QPs must meet specific educational and vocational requirements. They are usually expected to be members of the Royal Pharmaceutical Society, the Royal Society of Chemistry or the Royal Society of Biology. These professional bodies jointly undertake assessment of the candidate’s eligibility on behalf of the VMD. Exceptionally, the VMD can appoint someone as a QP on a restricted named-site basis only.
QPs must comply with the QP Code of Practice. Guidance on the professional duties and responsibilities of the QP is in Eudralex Volume 4 Annex 16.
Production Manager (PM)
An applicant for a ManA must nominate a suitably qualified Production Manager (PM). Their responsibilities are defined in Eudralex Volume 4, Chapter 2.
Quality Control (QC)
An applicant for a ManA must nominate a suitably qualified Head of Quality Control (QC). The Head of QC cannot be the same person as the PM but they may also be the QP. Their responsibilities are defined in Eudralex Volume 4, Chapter 2.
The VMD can issue a ManA solely to authorise the holder to certify and release batches of products for which they hold the MA where the medicine has been manufactured by a contract manufacturer.
The QP named on a ManA granted solely for the purpose of batch certification may either take responsibility for all manufacturing stages conducted by the contract manufacturer or may take account of the confirmation of the batch by the contract manufacturer’s QP. Ultimate responsibilty for batch certification of the batch lies with the certifying QP.
The record requirements are defined in the Veterinary Medicines Regulations (VMR). The records for each batch must include:
- the name of the product
- the quantity manufactured, assembled or supplied
- the date of manufacture, assembly or supply
- the batch number and expiry date
- the name and address of the recipient, where supplied
- all certification provided by the QP related to the batch
All records and certificates must be kept for at least five years from the date that the batch is placed on the market or one year after the expiry of the batch whichever is the longer.
Export to a third country
Veterinary medicines manufactured in the UK should be produced to the same standards irrespective of where they will be used. If you are manufacturing medicines in the UK exclusively for export to third country (a non-EU or EEA country) you need a ManA and must comply with GMP.
The VMD will inspect your manufacturing site to ensure you comply with the EU GMP principles.
Manufacture of products under the Exemption for Small Pet Animals
Medicines manufactured under Schedule 6 of the Veterinary Medicines Regulations (the Exemption for Small Pet Animals) must comply with GMP and be manufactured by the holder of a manufacturing authorisation issued under:
- Directive EC No 2001/82 as amended (sites in UK and EU)
- a certificate issued by the competent authority (sites in Australia, Canada, New Zealand and Switzerland)
- a certificate issued by the Secretary of State (sites in all other countries)
There are no restrictions on the retail supply within the UK of products manufactured under the exemption but they may only be wholesale supplied by the holder of a WDA.
There are no restrictions on the importation of products which fully comply with this exemption.
Further guidance on the exemption is available on GOV.UK