Frequently asked questions about marketing authorisations

Fimea advises marketing authorisation holders to also follow the updates made to the CMDh and CMDv websites.

Brexit-related guidance for companies (EMA)

Common guidelines from the Commission to prevent problems in the supply of medicines (25 February 2019)

14 Sep 2022

The marketing authorisation or registration holder or the manufacturer responsible for batch release may be located in the United Kingdom until the end of the transition period (31 December 2020).  The QPPV or PSMF of a medicinal product may also be located in the United Kingdom until 31 December 2020. As the negotiations between the EU and the UK proceed, more detailed information will be provided on what will happen from 1 January 2021 onward when the transition period comes to an end.

14 Sep 2022

Simultaneous marketing will also be possible after Brexit. A Qualified Person (QP) who is located in the UK may release the medicinal product to the EU/EEA market until the end of the transition period (31 December 2020). -> additional transition period of three years, i.e. ad 31 Dec 2024

14 Sep 2022

Batch control may be normally located in the UK during the transition period, and there is no need to request for an exemption during this time.

14 Sep 2022

The United Kingdom cannot act as a Reference Member State after 31 January 2020. The marketing authorisation holder cannot take any regulatory actions in respect of its marketing authorisations until a new Reference Member State has been assigned to replace the United Kingdom. However, the United Kingdom may continue its actions normally as a Concerned Member State.

14 Sep 2022

Human medicines: mrp(a)fimea.fi

Veterinary medicines: vet.applications(a)fimea.fi

14 Sep 2022

Perforated blisters should be registered as unit-dose blisters in accordance with the EDQM definition for the standard term ”unit-dose blister “. In the application form, the summary of product characteristics, the package leaflet and on the outer carton the pack size should be stated as e.g. “20 x 1 tablets”. All the labelling information required for the blister packs should appear on each unit dose presentation.

14 Nov 2016

A medicinal product can only be on the market with one composition. A medicinal product with the old composition must be withdrawn from pharmacies and wholesalers before the product is introduced on the market with a new composition. The marketing authorisation holder must notify Fimea (notification of placing a medicinal product on the market) when the medicinal product is introduced on the market with the new composition. If justified, Fimea may grant a permission for releasing both the old and new composition to the market for a maximum of six months. The request for simultaneous marketing must be presented along with the variation application.

18 Apr 2019

The marketing authorisation holder is responsible for determining whether, during the MRP/DCP process, a therapeutic indication was approved that is protected by a patent valid in Finland. The therapeutic indication and references to it can be deleted from national texts either during the national phase of the marketing authorisation application or a national type IB variation (subtype C.I.z). A therapeutic indication and references thereto that were deleted due to a patent can be added into national texts by means of a national type IB variation (subtype C.I.z).

30 Apr 2021

If the variation application concerns several variations, a separate notification or application should be submitted for each variation. However, the variations may be grouped in accordance with Article 7 of Commission regulations 1234/2008 and 712/2012. For example, if the application concerns three different Type II C.1.4 subtype variations, these must grouped in one application containing three Type II C.1.4 subtype variations. Applicants should note that implementing changes made to the Company Core Data Sheet (CCDS) in product information may involve several separate variations. Applicants must clearly state the topic of each change on the application form. For clinical Type II variations a single variation refers to the actual change and other related changes or to consequential changes resulting from the actual change. CMDh has published explanatory notes on how to fill in the application form, examples for acceptable and not acceptable groupings, and questions and answers regarding groupings.

Please see separate instructions for submitting a summary of product characteristics in Swedish.

29 Apr 2021

The Marketing Authorisation Holder is responsible for implementing the changes to production according to their own quality system. The changes must be implemented as soon as possible, from the next possible production run. In exceptional cases a separate implementation time can be agreed during variation procedure. 

9.6.2023

Yes, the list of products to be stocked as mandatory reserve supplies is a national list of critical medicinal products. Therefore, for shelf life reduction variations concerning these products, condition 6 is not fulfilled, and the variation applications must be upgraded to type IB.

23.4.2026

Classification as a medicinal product

Fees related to the processing of a marketing authorisation application: Decree issued by the Ministry of Social Affairs and Health on fees chargeable by the Finnish Medicines Agency

Fimea regulation 04/2019: Applying for and maintaining a marketing authorisation for a medicinal product

Fimea’ guidelines on marketing authorisations

Application forms: Applications related to marketing authorisations

Scientific advice

Pharmaceutical legislation of the EU Eudralex

Instructions of the European Commission for applicants of marketing authorisation: European Commission: Reference documents: Eudralex: Volume 2 - Pharmaceutical Legislation: Notice to applicants and regulatory guidelines medicinal products for human use

29 Apr 2021

Centralised procedure: EMA guidelines

Mutual recognition and decentralised procedures: CMDh instructions (Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human)

Updated 9.6.2023

Fimea has decided that in Finland, a medicinal product can have package sizes that are authorised for marketing both as prescription and OTC products. In such a case, the prescription and OTC packages have different Vnr numbers. Moreover, the instructions require that packaging labels usually differ a little between the prescription and OTC package.

30 Apr 2021

QRD-template-compliant updates to the summary of product characteristics, package leaflet or labelling can be submitted along with a clinical Type IB or Type II variation application. If the structure of the package leaflet of a medicinal product changes significantly as a result of QRD template updates, the update cannot be done along a Type IB variable, variation application. Instead, the update must be carried out either as a separate Type IB variation application (subtype C.I.z) or along with a clinical Type II variation application. Small and individual QRD template amendments can be made to the package leaflet and the labelling by filing a so-called 90-day notification.

29 Apr 2021

If the medicinal product whose marketing authorisation is cancelled has a shared SPC or package leaflet with a strength or pharmaceutical form whose marketing authorisation remains in force, the information in the cancelled marketing authorisation can be deleted from the shared text with a Type IB variation application (subtype C.I.z.). Alternatively, the information can be delete along with another variation application that affects the texts (but not in connection with the submission of a summary of product characteristics in Swedish), or by submitting a so-called 90-day change notification, if only the package leaflet is common across strengths and pharmaceutical forms.

29 Apr 2021

Regarding the pictures instructing the recycling of the empty medicine package, the guidelines of the European Medicines Agency's 'Working Group on Quality Review of Documents' (QRD) are followed, and according to the current guidelines, recycling pictograms cannot be added, for example, to the outer surfaces of the outer packaging.

However, it is acceptable to add the recycling pictograms regarding packaging materials to the inner surfaces of the outer packaging so that they become visible only when the packaging is opened.

In Nordic packages, the position of other Nordic countries on the recycling markings appearing on the packaging must be taken into account.

22 Apr 2024

When an applicant is being granted a marketing authorisation, they must submit mock-ups for each type of packaging and strength or an explanation of how the mock-ups of different strengths will differ from each other. In any case, mock-ups have to be submitted of all the strengths and packaging types that will be placed on the market. Also, mock-up versions always have to be submitted separately for both Non-prescription (OTC) and prescription-only (POM) packaging if both legal status for supply are approved in the marketing authorisation. 

If the marketing authorisation holder does not intend to place all the packaging types on the market, they can submit a declaration to Fimea that mock-ups will be submitted to Fimea for approval with Type IB variation before placing them on the market. In any case, one set of mock-ups always have to be submitted for both the prescription and OTC status when a marketing authorisation application is granted if both are approved in the marketing authorisation; alternatively, see the conditional marketing authorisation below. 

If the marketing authorisation has been granted with an explanation of how the mock-ups will differ from another strength, a mock-up proposals with a separate 90-day notification has to be submitted to Fimea before placing the label to on the market.

If the marketing authorisation holder does not want to submit any mock-ups when being granted a marketing authorisation, the marketing authorisation holder can apply for a conditional marketing authorisation, in which case the marketing authorisation is granted entirely without national translations, using only English versions of the summary of product characteristics, the package leaflet and the labelling.  The product in question can only be placed on the market in Finland once Fimea has approved the national summary of product characteristics, package leaflet and mock-ups submitted with a Type II variation application.

If changes are made to the labels in the variations, the marketing authorisation applicant has to update the mock-ups approved by Fimea. If the variation concerns a new packaging type, a mock-ups has to be submitted for all the strengths subject to the marketing authorisation application. If a new packaging type is not being placed on the market, the marketing authorisation holder can submit a declaration that the mock-ups will be submitted to Fimea for approval with Type IB variation before placing them on the market.

30 Apr 2026

Fees related to the processing of a marketing authorisation application: Decree issued by the Ministry of Social Affairs and Health on fees chargeable by the Finnish Medicines Agency

29 Apr 2021

No.

29 Apr 2021

Yes. The fees are listed in the Decree issued by the Ministry of Social Affairs and Health on fees chargeable by the Finnish Medicines Agency. The fee is charged after the advisory session.

29 Apr 2021

Based on pharmaceutical legislation, it is still possible for the parallel importer to choose to use the new outer package or alternatively to label the old outer package. If the parallel importer ends up with the latter option, Fimea recommends covering the foreign language text on the packages to be labelled. The package must be clear and easy to read in Finnish and Swedish. However, a possible foreign language text must not conflict with the Finnish and Swedish text, and the marketing authorisation holder is responsible for the correctness of the foreign language text. For products with a different trade name in the country of acquisition, the trade name of the country of acquisition must be completely covered.

Fimea evaluates the package of the parallel imported product from the point of view of pharmaceutical legislation, and does not take a position on, for example, trademark law issues. It is the responsibility of the parallel importer itself to ensure that its operations (including product package) do not infringe the rights of other parties, for example a trademark. If so-called safety feature requirements are applied to the parallel imported medicinal product, the package must meet the conditions set for these safety features, which are stipulated, among other things, in Commission Delegated Regulation (EU) 2016/161 and Directive 2001/83/EC, which in terms of safety features is essentially implemented in the Medicines Act (395/1987) 30 q and 30 r in §."

Medical products under one marketing authorisation number must be packed using the same method.

19.6.2023

The role of the local representative has not been defined. The responsibilities and obligations belonging to the local representative can be agreed between the marketing authorisation holder and the party acting as the local representative.

The roles of the local representative and the marketer have not been defined. The responsibilities, the obligations and the used terms can be agreed between the marketing authorisation holder and the party acting as the local representative/marketer.

It is not recommended to mention the local representative or the marketer in the mock-ups because the size of the package for a medicinal product is limited. If the local representative is mentioned in the mock-ups, the details of the local representative must be separated from the details of the marketing authorisation holder by a heading and they must not affect the readability of the packaging. If the local representative is mentioned on the package, then it must also be mentioned on the package leaflet.

Yes. The local representative can be mentioned at the end of the package leaflet, but the information must have a clear heading. The same information should be provided at the end of the Finnish and Swedish versions of the text.

It is recommended that, in addition to the name, also the contact details of the local representative are mentioned in the package leaflet so that the party in question can be contacted by phone or email. The address can also be mentioned. A website address must not be mentioned.

The name or the logo of the local representative is sufficient in the mock-ups. Also see the question “Can the local representative be mentioned in the mock-ups of a medicinal product”?

Fimea does not need to be informed about the local representative unless the local representative is mentioned in the package leaflet or in the mock-ups of the product.

The details of the local representative can be changed in the package leaflet (and in the mock-ups as necessary) by submitting a 90-day notification in the case of medicinal products intended for human use. The change can also be made in connection with an application for a Type IB or Type II variation that affects the texts. With type IA/IAin variation applications, the change can only be made to those documents that are updated with the application anyway. For veterinary medicines The EU Veterinary Medicines Regulation (2019/6) is applied.

The local representative may act as the marketing authorisation holder’s contact person in communication with Fimea. In that case, in addition to the package leaflet, the details of the local representative should also be submitted to Fimea by using the official form “Contact details - communication between marketing authorisation holder and Fimea”, which can be found on Fimea’s website. The contact person for the medicinal product may also be a party that is not the local representative.

The primary means of submission of a Swedish SPC (national type IB (C.I.z) application), for veterinary medicinal products VRA (E.z)) is through CESP in eCTD format. A Swedish SPC can also be submitted outside the eCTD. If sent by post, the submission should be accompanied by a paper cover letter and include the material in electronic format on a CD. For additional information, please see the instructions for electronic marketing authorisation submissions.

17 Jan 2022

• cover letter - If Sweden and Finland have participated in the same process and the Swedish Medical Products Agency (MPA) has approved a Swedish SPC for the product, this should be indicated in the cover letter. The cover letter must also include a declaration that the Swedish SPC approved by MPA is identical in substance to the Finnish SPC.
• application form
• a SPC in Finnish and in Swedish in Word format
• the latest approved common SPC, if applicable

1 Dec 2020

If the products in the same product family have a common SPC, you can submit only one application of type IB C.I.z. If the products of the product family have separate SPCs and differ from each other (e.g. in terms of indications, posology or method of administration) the SPCs should be submitted as separate applications.

25 Jun 2020

Changes to the package leaflet are not allowed in connection with submitting a SPC in Swedish. It is possible, however, to submit a separate 90-day variation application regarding changes to the labelling or package leaflet or a type IB variation application regarding the package leaflet to be processed at the same time.

25 Jun 2020

By way of exception, submitting a summary of product characteristics in Swedish can’t be combined with other variations (e.g. warnings for excipients or template updates). Only correction of minor individual mistakes is allowed.

In accordance with the grouping rules, other clinical variations can be grouped together in the same application. In this case, it is possible to make other variations as well.

25 Jun 2020

This doesn’t change how the translations of the centralised medicines are coordinated.

8 Feb 2019

Yes, the summary of product characteristics in Swedish is needed for veterinary medicinal products as well.

11 Feb 2019

A 3 year transition period is applied for submitting of a summary of product characteristics in Swedish for already granted Marketing Authorisations and for Marketing Authorisation applications which are submitted before 9.2.2019.

11 Feb 2019

For Marketing Authorisation applications which are submitted after 9.2.2019 a Swedish summary of product characteristics is required and the Marketing Authorisation will not be granted without it. For Marketing Authorisation applications which are submitted before 9.2.2019 a Swedish summary of product characteristics can be submitted by a national type IB variation after the Marketing Authorisation is granted. The Swedish summary of product characteristics can also be submitted at the national phase of the Marketing Authorisation application.

11 Feb 2019

A summary of product characteristics in Swedish can’t be combined for exampla with a renewal, type II variation application or with an application of transfer of a marketing authorisation to a new holder. Addition of a summary of product characteristics in Swedish must be applied by a national type IB variation, which can be grouped with an appropriate clinical (classification C) variation.

4 Apr 2019

A summary of product characteristics in Swedish should be submitted with a national type IB variation (C.I.z) for already approved medicinal products.

11 Feb 2019

A summary of product characteristics (SPC) in Swedish should be submitted in one Word-document following the Finnish version of the SPC same way as the package leaflet is submitted already. Both Finnish and Swedish summary of product characteristics need to have the same date.

25 Jun 2020