The EU Commission has already created a Questions & Answers document (see our GMP News from 24 April 2013) addressing the most important questions with regard to the Written Confirmations for APIs imports from non-EU Countries. In practice though, problems keep on arising for which no satisfying answer can be found in this Q&A document so that many companies address their questions directly to the respectively competent authorities. The DHMA (Danish Health and Medicines Authority) has recently compiled a range of questions and published them together with their answers in a document entitled "Requirements for import of active substances (API) - question and answers" on its website.
Regarding the content, some of the questions are similar to those already addressed in the Q&A document of the Commission. Nevertheless, the answers are quite differentiated and partly reflect the country's specific handling of requirements on APIs imports. Find below some examples:
- Question: Do the rules on the written confirmation also apply to active substances of investigational medicinal products?
Answer: Yes, but only if the investigational medicinal product has a marketing authorisation. (In the Commission's document, the answer to this question is basically "no").
- Question: If the need arises to waive the requirement for a written confirmation (e.g. because of a risk of shortage) and the active substance is imported in one EU country and subsequently in other EU countries, will all authorities of the EU countries then have to waive the requirement?
Answer: No. It is up to the competent authority of each Member State to address the question of potentially waiving the requirement for a written confirmation.
- Question: Will the DHMA check how authorities in third countries issue Written Confirmations?
Answer: There will be no routine control of Written Confirmations. However, the EU authorities will perform random-based inspections at certain sites on a risk-based approach. If it turnes out that an API manufacturer doesn't comply with GMP, this will lead to the usual consequences for the pharmaceutical companies - which are the potential withdrawal of the concerned medicinal products from the market.
- Question: Will inspections of active substance manufacturers carried out by non-EU countries be accepted as a basis to waive the requirement of a written confirmation?
Answer: No. The requirement can be waived only when the manufacturing site of the active substance has been inspected by an EU authority and is covered by a valid GMP certificate.
The general approach of how to handle situations in which the import of APIs is blocked because of a missing Written Confirmation has been addressed in detail in a guideline of the Heads of Medicines Agencies (HMA) which has been published recently (please also see our News from 17 July 2013).