Risk-based Approach to APIs Consignments without Written Confirmation

Since 2 July of this year applies the following: deliveries of APIs from non-EU countries into the EU must be accompanied by a Written Confirmation. Countries which the Commission has identified beforehand that their legislative framework for the inspection and enforcement of GMP-compliant API production is at least equivalent to the EU standards are excluded from this provision. So far, these countries are Japan, the United States, Switzerland and Australia. They are recorded by the EU-Commission in a so-called "third countries" list. Other important APIs exporting countries such as India and China currently issue Written Confirmations.

The provisions of the directive are intended to ensure that API manufacturers in non-EU countries exporting into the EU are registered with their local authorities and subject to adequate regulatory oversight. However, there are a number of countries which haven't prepared for this requirement until now. Therefore scenarios are rather likely according to which the onward transport of APIs to their destination will be denied and the consignment remains in quarantine at the EU external borders.

To ensure a consistent approach for the release of APIs consignments and their transport in such cases, the Heads of Medicines Agencies (HMA) of the EU Member States have published a guideline. The core of this guideline is a decision tree that defines for different scenarios how the importer of the API (usually the agent or distributor) has to proceed to release the API batches from the quarantine. First of all, the importer must seek to get a written confirmation. If this doesn't succeed, he is obliged to create a risk assessment and to provide it to the national competent authority (NCA) of the importing country. The risk assessment has to provide answers to the following questions:

  • Why could no written confirmation be received from the authority of the exporting country?
  • What are the levels of stocks currently available to the manufacturer of the medicinal product for which the active substance is to be used? 
  • What are the indications for the product for which the active substance is to be used?
  • Which alternative products and treatments are available?

These risk assessments are in turn assessed by the respective NCAs of the importing countries and provide the basis for decisions to be taken if necessary regarding the performance of a GMP inspection at the API manufacturer's site. They are also an important source of information for the EMA to monitor the situation on the pharmaceutical market in terms of possible supply shortages.

The procedure described in the guideline should be applied for a not yet defined transition period only. On the basis of the information from the risk assessments, the EMA will be able to coordinate GMP inspections where necessary and ultimately assess the duration of this "interim period".

For further information please see the HMA Guideline entitled "Importation of active substances".

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