SC IV C. Certification Scheme

1. The scheme is operated in accordance with the procedures described in Council of Europe Resolution AP-CSP(07) 1. Additional information, including a list of certificates granted, is published regularly in Pharmeuropa.

2. The scheme has been extended by means of Resolution AP-CSP(07)1 and Directives 2001/83/EC and 2001/82/EC as amended, of the European Union to cover active substances or excipients (organic or inorganic, obtained by synthesis, extraction or fermentation), any product with transmissible spongiform encephalopathy (TSE) risk, or herbal products used in the production or preparation of pharmaceutical products.

3. For the established process, the certificate is a ‘Certificate of Suitability of a Monograph of the European Pharmacopoeia’. It certifies that the relevant Ph. Eur. monograph adequately controls the substance as manufactured by the company concerned at the time that the certificate is granted (mainly that the impurity tests are adequate to control the impurity profile associated with the particular source/route of synthesis). It is not a certificate of compliance. It does not certify that the substance, as manufactured by the company concerned at the time that the certificate is granted, complies with the requirements of the relevant Ph. Eur. monograph.

4. The Certification Scheme is recognised by all signatory states of the European Pharmacopoeia Convention and the European Union. Canada, Australia, New Zealand, Tunisia and Morocco also recognise the scheme.

5. The certificate is intended to facilitate the licensing process. It can be used to simplify the data required within the Control of starting materials section of an application as stated in the amended Annex to European Community Directive 2001/83/EC and the associated EC Guideline on Requirements in relation to active substances. The Certification Scheme is intended to operate in an analogous fashion to that for European Drug Master Files (EDMFs) for which it is the preferred alternative. Its general purpose is to avoid duplication of work by marketing authorisation applicants in preparing dossiers and by the authorities in the assessment process. The scheme also assists in eliminating differences in the interpretation of Ph. Eur. monographs by various competent authorities. The operation of the scheme provides the European Pharmacopoeia Commission with a mechanism for updating monographs, for example, to cover substances made by different manufacturing methods.

6. The scope of the procedure was extended by means of Resolution AP-CSP(07)1. It now covers substances produced by fermentation as indirect gene products, which are metabolites of microorganisms, irrespective of whether or not the microorganisms have been modified by traditional procedures or r-DNA technology and products with risk of transmitting agents of animal spongiform encephalopathies (TSE). Substances which are direct gene products, such as proteins, and substances obtained from human tissues, vaccines and blood products and preparations remain excluded from the Certification procedure. The final decision on eligibility of an application for a certificate of suitability for a material of animal origin is taken by the relevant board of the procedure if necessary.