Post-marketing obligations for parallel imported medicinal product
The price for prescription medicinal products that have MA(PI) has to be approved by NoMA. An approved price will not be available until a MA(PI) is granted. The application form is available on the Norwegian Medicines Agency's website.
Approval of samples
It is not mandatory to submit the sample package. Norwegian Medicines Agency may ask for a scan and/or photography of the printed inner and outer packing.
A renewal application for the marketing authorisation has to be sent to NoMA, no later than nine months before the due date. A relevant renewal application form is available on NoMA’s website. It is not necessary to enclose/attach mock-ups. If the marketing authorisation is not renewed before its expiration, an immediate decision of MA(PI) withdrawal shall take effect, without further verification to the MAH.
A fee for each application for renewal has to be paid, i.e. for each strength and each pharmaceutical form, and for each export country of the same medicinal product. More information about fees on this page.
The parallel importer has to keep informed about any changes to the parallel imported medicinal product. NoMA has to be informed continuously on this matter by sending a relevant application form for updates.
NoMA has to be informed if the parallel imported medicinal product changes appearance, excipients declaration, package size, package type, and pharmaceutical form; MAH in the export country, manufacturer, shelf life, storage conditions, registration status or MAnumber in the export country. The same applies if the parallel imported medicinal product with MA(PI) changes package size or manufacturer.
An updated application has to be submitted also in the cases when the directly imported medicinal product is updated, which may lead to differences between the parallel imported and directly imported medicinal product. The parallel medicinal product may still be on the Norwegian market, unless NoMA decides otherwise. Norwegian Medicines Agency must immediately be informed, if the Power of Attorney for a representative of the marketing authorisation holder has declined. MAH(PI) shall immediately notify on who may be the new representative.
If the conditions for parallel import no longer are considered to be fulfilled, the MA(PI) shall be withdrawn. NoMA has to be informed when the MAH(PI) no longer intends to maintain the authorisation for the medicinal product. More information and form for withdrawal on this page.
According to the Norwegian Regulation for medicinal products of 18th December 2009, Art. 8-4, first paragraph, the marketing authorisation is withdrawn, if the medicinal product is not followed by actual placing on the Norwegian market within 3 years from the MA(PI) approval. 11 A MA(PI) shall be withdrawn, if the parallel imported medicinal product, previously placed on the Norwegian market, no longer is on the market for a period of three consecutive years. The Sunset clause procedure was implemented 10th January 2010.
Reporting of adverse events
NoMA encourages that all suspected adverse events following use of parallel imported medicinal products, reported to the parallel importer, are forwarded to the MAH for the original medicinal product. Parallel importers are encouraged to follow reporting requirements as described in the GVP Module VI, and Volume 9B (Notice to Applicants) for medicinal products for human and veterinary use, respectively.
Contact: MAH(PI) - email@example.com Adverse events (human) - firstname.lastname@example.org Adverse events (veterinary) - email@example.com