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You must obtain a manufacturing authorisation (ManA) and comply with Good Manufacturing Practice (GMP) to manufacture:

• an unauthorised veterinary medicine
• a medicine under Schedule 6 of the current Veterinary Medicines Regulation (Exemption for Small Pet Animals)

Manufacturers of human and veterinary products

Where a site handles both human and veterinary medicines you should also refer to guidance published by the Medicines and Healthcare products Regulatory Agency (MHRA), who also publish a register of sites authorised to manufacture both human and veterinary medicines.

Manufacturing Authorisation (ManA)

You must be a ManA holder to 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 (secondary packing) before the medicine is sold or supplied; this includes the over-labelling of medicines

• batch certification of veterinary medicine manufactured at another site in the UK including contract manufactured products

• 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) are continuously available
• possess a current GMP certificate issued by a UK or EEA member national competent authority 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 products MA available to us, on request
• ensure the finished product is labelled with:
  1. registered name, strength and pharmaceutical form
  2. batch number
  3. expiry date
  4. storage requirements
  5. any warnings required for safe handling of the product
• ensure a representative sample of the finished product is retained and made available to us for testing upon request

Good Manufacturing Practice (GMP) Compliance

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 APIs 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)

You must comply with the European Commission document EMEA/410/01Rev 2 Notes for 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)

The QPs role and responsibility is defined in Eudralex Volume 4, Chapter 2 and Annex 16.

At least one QP must be named on the authorisation and must be permanently and continuous at the ManA holders disposal.

To place products on the GB market, QPs can be located anywhere. From January 2021, to place products on the Northern Ireland market, QPs must live in NI or the EEA.

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 candidates eligibility on our behalf. Exceptionally, we 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

Your ManA application must nominate a suitably qualified Production Manager. Their responsibilities are defined in Eudralex Volume 4, Chapter 2.

Quality Control

Your ManA application must nominate a suitably qualified Head of Quality Control (QC). The Head of QC cannot be the same person as the Production Manager but they may also be the QP. Their responsibilities are defined in Eudralex Volume 4, Chapter 2.

Batch certification

We 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 st

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