Application for MA for parallel importet medicinal products

Application form

The application form has to be submitted together with the required documentation. If the (legal) person authorised for communication on behalf of the applicant submits the application form, a «Power of Attorney» is required.

An application form for each strength and each pharmaceutical form, as well as for each export country of the same medicinal product, has to be submitted. For parallel import of medicinal products authorised through the centralised procedure, an application must be submitted for each strength and each pharmaceutical form of the same medicinal product, with the EU as export country.

Any future granting of marketing authorisation for parallel import of this type of medicinal product would include all countries in the EU/EEA.  

Content of the application

The application shall include:

1. Cover letter

2. Application form issued by NoMA

3. Draft of the labeling (mock-ups) in colour of the inner and outer packaging

4. Draft of the package leaflet

5. Scan and/or photography of the inner and outer packaging, as well as presentation of the contents of a package from each of the different original packages, intended for parallel import

6. Documentation on valid import authorisation granted by NoMA, if the applicant of the marketing authorisation for parallel import, MA(PI), itself shall import the medicinal product to Norway

7. Documentation from the company(s) that perform the re-labeling/repackaging on their valid manufacturing authorisation, granted by the regulatory authorities in the country/countries where the re-labeling/repackaging are performed

Any deviation from the directly imported medicinal product has to be reported in the application. Further, the applicant is required to make an assessment on the significance of this deviation of the therapeutic effect of the imported medicinal product and its use in general.   

Notification of patentee

When applying for parallel imports from Bulgaria, Estonia, Croatia, Latvia, Lithuania, Poland, Romania, Slovakia, Slovenia, Czech Republic or Hungary, the applicant shall attach documentation that the patentee or the holder of the supplementary protection certificate, or whoever derives their rights from this, is notified in accordance with the relevant regulations.

Reference is made to the Norwegian Regulation to the Patent Act of 14thDecember 2007 no. 1417 Art.100 and the Norwegian Regulation on medicinal products of 18thDecember 2009, Art 3-25. If this documentation is missing, an opportunity to deal with it shall be given, cf. the Norwegian Regulation for medicinal products Art.5-1, second paragraph.

If the matter is still not settled within the time limit, the application will be rejected, according to the Regulation for medicinal products Art. 5-9, first paragraph, b.

If the documentation requirement is met, the marketing authorisation application cannot be refused, even if there are objections from the licensee.

For parallel import of medicinal products authorised through centralised procedure, the above-mentioned notification process is required in like manner, if the applicant wants to make parallel imports from any of the aforementioned countries, prior to the submission of the application. If the applicant does not want to carry out this notification process prior to the submission, but at a later date, post-marketing authorisation, the patentee or the holder of the supplementary protection certificate, or whoever derives their rights from this, has to be notified at least one month before the import is carried out. Documented notification has to be submitted to NoMA.

NoMA does not take any position on patent disputes between the applicant and the licensee. If the licensee has objections to the import on patent rights ground, from a juridical aspect, the licensee, as for other referrals regarding parallel import, may do so by instituting proceedings in the courts.  

Labelling

Draft of the labelling of the parallel imported medicinal product shall be designed by following the packaging of the directly imported medicinal product as standard (i.e. according to the Norwegian Regulation on medicinal products Art.3-29 to 3-41).  

Perforated blister

Perforated blisters shall be formed as unit dose blisters. They shall be marked with the required information on each peelable unit, according to Art.3-35, from the Norwegian Regulation on medicinal products.  The name of the marketing authorisation holder, MAH(PI), shall be stated on the blister, but this is not required on each peelable unit.  

Storage conditions

Storage conditions are set according to Appendix III to the QRD templates for human 6  medicinal products. Any storage conditions other than "No special precautions for storage" shall be presented on the packaging.

The parallel importer shall always relate to the approved storage conditions in the export country.  

MA-holder (PI), importer, re-packer

Company name and address is presented in the following format: <company name>, <city/place>, <country, other than Norway>. Country code may be accepted instead of country name.  

Manufacturer

The manufacturer shall be featured on the outer packaging. The manufacturer is the one responsible for the batch release in the export country for the mentioned batch intended for sale on the Norwegian market. There may exist several manufacturers of the medicinal product in the export country, but only the manufacturer that is registered for the current batch will be featured on the outer packaging. Manufacturer(s) must be reported to the Norwegian Medical Products Agency. When the MA (PI) is granted, one or more manufacturers shall be registered. If there are changes on manufacturer(s) after providing MA(PI), these shall be reported to NoMA by applying for variation. The manufacturer's address shall be indicated in the following format: <company name>, <city / place>, <country, other than Norway>. Country code may be accepted instead of country name.  

Differences

When differences between directly and parallel imported medicinal product occur (such as (Invented) Name, how the tablet appears, calendar pack) they shall be clearly stated on the outer packaging front panel and, if space, on the inner packaging.  

Re-labeling / repackaging

In case of re-labeling, texts other than in Norwegian, may be used on the packaging material. The content may be accepted if it is not in conflict with the mandatory Norwegian requirements for labeling. Text in other language than Norwegian may be stuck over (relabeled) with Norwegian text label. In such cases, re-labelling has to be prepared so well that the underlying text does not shine through. It shall be ensured that the label sits so well that it does not fall off nor easily can be removed.

It is mandatory to submit to NoMA clean text and mock-up of the re-labeled package, i.e. how the package is planned to be re-labeled. Approval shall be granted for both design (location of the label on the original packaging) and text content. The inner labeling has to be displayed as it is intended to be brought out on the market. As for blisters/strips, copy or scan of the blister with the necessary labeling featured, is required submitted.

It is possible for the parallel importer to repack the parallel imported medicinal product instead of re-labelling it.

Parallel importers who do the repackaging or re-labeling need a manufacturing authorisation. Manufacturer authorisation is granted on application to NoMA. The company that is authorised for repackaging must be located in an EU/EEA country. It is sufficient to present the manufacturing authorisation from the Authority in the country concerned. A copy of the manufacturing authorisation has to be enclosed/attached to the application for marketing authorisation for parallel import.

Conditions relevant to the MA-application are set out in the application form. For instance, for the blisters that are planned to be repacked. The number of blisters laid in the relabeled/repacked package shall also be mentioned in the application form. It is mandatory to put same type blisters in one package. It is prohibited to cut off or in any other manner split a blister.

Package leaflet (PL)

A draft package leaflet shall be designed according to the Norwegian Regulation for medicinal products, Art.3-42 to 3-56. The direct importer’s package leaflet is normally used as a template for the draft of the package leaflet for the parallel imported medicinal product.

Declaration of excipients

Excipients shall be listed as in the Norwegian pharmaceutical standards (Norske legemiddelstandarder, NLS) 

Storage conditions

Storage conditions are set according to Appendix III to the QRD templates for human medicinal products. Every storage condition other than "No special precautions for storage» shall be featured on the packaging. The parallel importer should refer to the approved storage conditions in the export country.  

MAH(PI), importer, repacker

Complete addresses shall be displayed in the package leaflet.  

Manufacturer

The manufacturer shall be featured in the package leaflet. The manufacturer is the one responsible for the batch release in the export country for the relevant batch intended for sale on the Norwegian market. There may be several manufacturers of the medicinal product in the export country, but only the manufacturer listed for the relevant batch shall appear in the package leaflet.

Manufacturer(s) shall be reported to NoMA. When the MA(PI) is granted, one or more 8  manufacturers shall be registered. If there are any changes in manufacturer(s) post MA(PI) authorisation, they should be provided for by variation application to NoMA. The full manufacturer's address has to appear in the package leaflet.  

Other information

Any differences between the directly and the parallel imported medicinal product have to be presented. Such examples are difference in storage conditions, differences in tablet appearance, calendar packaging and different medicinal product names ((Invented) Names). The regulatory legislation does not prohibit gathered information about all strengths related to a pharmaceutical form are included in the same package leaflet, even when a parallel importer has approval for only some of the strengths.

NB! NOMA assesses only the strength and the country of origin applied for in the relevant application, with regard to the comments/information given. NoMA does not approve the parallel importer’s package leaflet.  

Repackaging

Parallel importers, who present package leaflet with Norwegian text in the package, must have manufacturing authorisation. A manufacturer authorisation is granted on application to NoMA. The company that is authorised for repackaging must be located in an EU/ EEA country. It is sufficient to present the manufacturing authorisation from the Authority in the country concerned. A copy of the manufacturing authorisation has to be attached to the application for marketing authorisation for parallel import.  

Summary of Product Characteristics (SmPC)

The parallel importer may refer to the SmPC of the directly imported medicinal product. If the direct importer no longer has the medicinal product on the Norwegian market, and it does not update the Norwegian SmPC, the parallel importer shall provide for translation to Norwegian of the SmPC from the export country. The parallel importer has always the responsibility for presenting or referring to the relevant SmPC in Norwegian.

Scan and/or photography of the inner and outer packaging, as well as the contents of the package

Scan and / or photography of the inner and outer packaging, as well as the contents of a package of each of the different original packages that are intended for parallel import, have to be enclosed/attached. However, it is possible to submit only a scan and/or photography of the smallest package size, given that the parallel importer verifies that the other package sizes intended for relabeling/repacking are designed similarly.

The Norwegian Medical Products Agency may request that samples are forwarded at any time during the application management.

Prescription group

Upon issuing a marketing authorisation for parallel import, the parallel imported medicinal product is granted with the same prescription group as the directly imported medicinal product.

If, at a later point of time, the directly imported medicinal product is granted with an exemption from the prescription requirement for one or more packages, then the parallel importer has to apply for the same prescription exemption, for the same package size(s), accordingly. In this application, a draft of the new package leaflet and draft of the new labeling (mock-ups) have to be attached; in the case of the prescription group CF, it may be required  another package leaflet and labeling, depending on the package size.

Fee

A fee shall be paid for each application, i.e. for each strength and each pharmaceutical form, and for each export country of the directly imported medicinal product.  A fee list is available on NoMA’s website.  

Management of the application

If the application is incomplete, the applicant shall be requested to correct the deficiencies in accordance to the Norwegian Regulation for medicinal products Art. 5-1, second paragraph. If the matter is still not settled within the time limit, the application will be rejected, according to the Norwegian. Regulations on Medicines Art. 5-9, first paragraph a. The application shall be assessed when it is complete and fees are paid. The management deadline has a 120 days’ timeline starting from the day when all the required information from the export country is received.  

Granting authorisation for parallel import

The marketing authorisation shall be granted, when the conditions for parallel import are fulfilled, and the medicinal product name, labeling, package sizes, packaging and technical equipment are approved.