Information on WHO Certificates issued by the BfArM in accordance with Section 73a sub-section 2 AMG
In accordance with Section 73a sub-section 2 AMG, the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) issues a certificate corresponding to the World Health Organisation's Certification Scheme, at the request of the pharmaceutical entrepreneur located outside the scope of the German Medicines Act (Arzneimittelgesetz, AMG) as far as the information relates to licensing issues.
- The applicant must submit all documents relevant for the decision on issuing of the World Health Organization (WHO)-Certificate.
- In cases in which a representative requests a certificate, the permission of the product-license holder is necessary. A corresponding written power of attorney is to be presented.
- The certifying authority has to ascertain that the information is accurate and up-to-date.
As a rule, separate certificates are to be requested for each distinguishable product and each marketing authorisation number (Zulassungs-Nr.) as well as for every importing country.
-> Each already filled out CPP is to be submitted together with the enclosures (if necessary) in a separate ZIP container.
The certificates are generally prepared by the applicant with regard to content and are to be sent to the following e-mail address: CPP@bfarm.de
- The parameters of the WHO's model certificate are to be adhered to. Irrelevant text passages must not be omitted, i.e. blanks in sections for which it is not intended or possible to make any statements, remain empty. If necessary, additions (e.g. trade name in the importing country) can be included for transparency purposes as an appendix.
- Appendixes belonging to the certificate must be attached in a neutral version (without company logo; does not apply to samples, e.g. the package leaflet) and at least in German. A further official WHO language (English, French, Spanish) can be considered.
- In accordance with Section 23 of the Law on Administrative Proceedings ("Verwaltungsverfahrensgesetz)", the official language is German. The foreign-language part (according to the official WHO translation) of the synoptically structured certificate is neither signed nor sealed/stamped by the authority (cf. item 3.10 of the WHO guidelines). Issuing of a synoptically structured certificate in a language for which the WHO does not offer an official translation, is possible after submission of the translation from a state-approved translator whose signature is to be notarised.
- The "General Instructions" and "Explanatory Notes" are an integral part of each certificate and must always be attached.
So-called "Hague Apostilles" cannot be affixed to WHO Certificates in accordance with Section 73a sub-section 2 of German Drug Law (AMG). The German Federal Ministry of Justice has pointed out that affixing an apostille to health certificates for commercial use is not permissible in accordance with Article 1 sentence 3 letter b of the Convention Abolishing the Requirement of Legalisation for Foreign Public Documents (Hague Convention of 5 October 1961 Abolishing the Requirement of Legislation for Foreign Public Documents). Health certificates in connection with the export of products to foreign countries are also trade certificates at the same time. Such certificates are characterised by the fact that they confirm especially the domestic licensing of medicinal products or food and the monitoring of their manufacture.
If a confirmation of authenticity is required abroad in connection with the presentation of these health certificates, they are to be verified and legalised by the relevant foreign consular representation.
Further information can be found on the internet pages of the German Federal Foreign Office under the following link.
Please note that the BfArM is only responsible for information relevant for licensing. Therefore, the "not applicable“ box is to be ticked under item 3. as this refers to GMP-related information. Thus, if item 3. of the WHO Certificate is to be certified, the pharmaceutical entrepreneurs have to request a separate WHO Certificate from the competent authority. If the manufacturing site is in Germany, certification of item 3. is done by the competent authority of the German state ("Landesbehörde").
Please also consider the explanatory notes on the individual items in the annex to the WHO Certificate as well as the WHO guidelines.