Amending regulation - manufacturing exception is introduced

Patents: Amending regulation (EC) No 469/2009 concerning supplementary protection certificate for medicinal products.

Patents: Amending Regulation (EC) No 469/2009 concerning supplementary protection certificate for medicinal products.

As of July 1, 2019, a manufacturing exception is introduced from the rights that the proprietor of a supplementary certificate has. Provided that the manufacturing is done for the purpose of exporting the products outside the EU, manufacturers of generic drugs and biosimilars will be able to commence manufacturing and/or storing during the protection period of the supplementary protection certificate.

The manufacturing exception will mainly apply to supplementary protection certificates that are applied for on or after the date of entry into force of the Regulation.

The exception applies under certain conditions, among them, the maker is obliged to inform the holder of the certificate and the relevant national authority, in Sweden it is PRV, where manufacturing and/or storing take place.

Information to be provided to PRV no later than three months before the start of the making is
a) the name and address of the maker.
b) an indication of whether the making is for the purpose of export, for the purpose of storing or for the purpose of both export and storing.
(c) the Member State in which the making and, if applicable, also storing is to take place, and the Member State in which the first related act, if any, prior to that making is to take place.
(d) the number of the certificate granted in the Member State of making, and the number of the certificate granted in the Member State of the first related act, if any, prior to that making; and
(e) for medicinal products to be exported to third countries, the reference number on the marketing authorisation, or the equivalent of such authorisation in each third country of export, as soon it is publicly available.

Form to be used for notification to PRV:

Form for notification, in English

Form for notification, in Swedish