When applying for a licence for the manufacture of a veterinary medicinal product, the Veterinary Medicinal Products Unit (BD) processes this application. Subsequently, advice is requested from the Health Care and Youth Inspectorate (IGJ) about whether the relevant licence requirements for manufacturing veterinary medicinal products and the relevant GMP requirements have been met.
Manufacturing is defined as:
The performance of one or more sub-operations necessary for the manufacture, including preparation, processing, handling, packaging (including filling and sealing the primary packaging), labelling or releasing a veterinary medicinal product for the market for which a marketing authorisation has been obtained, or that is exempt from this (according to Art. 2.19, section 1 of the Animals Act, Art. 1.1, section 5 and Art. 4.1 of the Veterinary Medicinal Products Decree and Art. 4.8 of the Veterinary Medicines Regulations).
The requirements for manufacture are described in:
- Veterinary Medicinal Products Decree (Art. 4.8 and 4.9)
- Veterinary Medicinal Products Regulations (Art. 4.4 – 4.9)
- The Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use.
Good Manufacturing Practice (GMP) is essential in manufacturing.
Good Manufacturing Practice (GMP)
Good Manufacturing Practice (GMP) is a quality assurance system for the pharmaceutical industry. The quality of a veterinary medicinal product can only be assured with a carefully defined and controlled production process.
Veterinary medicinal products must therefore always be produced and checked in accordance with:
- the quality regulations for the application in question, and
- the requirements for the marketing authorisation.
The principles of GMP are set out in legislation and in the Guidelines for Good Manufacturing Practice (EU Directive 1991/412/EC).
Volume 4 of The rules governing medicinal products in the European Union, Good Manufacturing Practice (GMP) Guidelines, include a manual for applying the GMP guidelines and principles.
Manufacturers of raw materials that comply with the GMP guidelines can request a ‘Certificate of Suitability to the monographs of the European Pharmacopoeia’. Additional requirements apply.
Certificate of Suitability to the monographs of the European Pharmacopoeia
The European Directorate for the Quality of Medicines & Healthcare (EDQM) issues Certificates of Suitability to the monographs of the European Pharmacopoeia (CEPs) to manufacturers of raw materials. A CEP is a confirmation that the pharmaceutical substance or active ingredients have been produced in accordance with the quality regulations for the preparation of medicinal products.
The EDQM’s inspectors investigate whether manufacturers comply with GMP and whether their production processes are in line with the approved CEP dossier. Inspectors from member states of the European Union and the European Economic Area (EU/EEA) also contribute to these inspections.
The Certification Database on the EDQM website shows whether a CEP is valid. The EDQM can suspend or withdraw a CEP for the following reasons, among others:
- Inspection of the manufacturer of the raw material shows that the manufacturer has not complied with GMP or CEP requirements.
- The manufacturer of the raw material refuses to allow the inspection.
- On request from a manufacturer of a raw material:
- if they are temporarily unable to produce in accordance with the approved CEP dossier
- if production is stopped, the factory is closed or the CEP is no longer applicable.
The Veterinary Medicinal Products Unit will endeavour to remove manufacturers with a suspended or withdrawn CEP from the marketing authorisation dossiers. Depending on the type of marketing authorisation, the Veterinary Medicinal Products Unit will seek coordination at the European level.