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New rules on importing active pharmaceutical ingredients into the EU – information leaflet

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…Who issues the written confirmation?

Written confirmation is issued by the regulatory authority of the country where the manufacturing site is located. You need to request it from that authority.

…Does written confirmation need to be issued for each batch/consignment’?

No. Written confirmation is issued per manufacturing plant and for each active substance(s) manufactured on that site.

…Does each imported consignment have to be accompanied by written confirmation?

Yes. However, it may be a copy of the written confirmation issued by the regulatory authority.

…Are there exceptions from the written confirmation requirement?

The Commission publishes a list of countries which, following their request, have been assessed and are considered as having equivalent rules for good manufacturing practices to those in the EU. Active substances manufactured in such countries do not require a written confirmation.

…Do I need written confirmation, even though my manufacturing site has recently been inspected by an EU Member State or by the European Directorate for the Quality of Medicines (EDQM) of the Council of
Europe?

Yes. The process of written confirmation is independent of such inspection activities. However, exceptionally and where necessary to ensure the availability of medicinal products, following inspections by an EU Member State, a Member State may decide to waive the need for a written confirmation for a period not exceeding the validity of the GMP certificate.

…Is written confirmation also required where there is a ‘mutual recognition agreement’ between my country and the EU?

Yes. The process of written confirmation is independent of the existence of ‘mutual recognition agreements’.

The European Union (EU) has reformed the rules for importing into the EU active substances for medicinal products for human use.

As of 2 January 2013, all imported active substances must have been manufactured in compliance with standards of good manufacturing practices (GMP) at least equivalent to the GMP of the EU. The manufacturing standards in the EU for active substances are those of the ‘International Conference for Harmonisation’ – ICH Q7.

As of 2 July 2013, this compliance must be confirmed in writing by the competent authority of the exporting country. This document must also confirm that the plant where the active substance was manufactured is subject to control and enforcement of good manufacturing practices at least
equivalent to that in the EU.

The template for such written confirmation can be found overleaf. This must accompany the active substance being imported into the EU.

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