The purpose of this document is to inform the applicant for marketing authorisation and marketing authorisation holder on changes to existing regulatory procedures to be implemented in the Czech Republic and other EU Member States to reflect the application of   amendments to EU regulations governing medicines. Included are, in particular, current issues of relevance to the regulatory practice in the transitory period before the amended EU regulations are transposed to the national legislation of the Czech Republic and some other EU Member States. Supplementation with other questions and answers on an ongoing basis is foreseen.  

Essential information for applicants for marketing authorisation of medicinal products  

What is a medicinal product?

A medicinal product shall mean any substance or combination of substances presented for treating or preventing a disease in human beings or animals. A medicinal product shall also mean any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying their physiological functions.

A human medicinal product shall mean a medicinal product intended for administration to human beings. A veterinary medicinal product shall mean a medicinal product intended for administration to animals.

Veterinary products are within the powers of the Institute for the State Control of Veterinary Biologicals and Medicaments - www.uskvbl.cz. A proprietary medicinal product shall mean any medicinal product in the finished form placed on the market under a special name and in a special pack.

Is the product I wish to obtain marketing authorisation for a pharmaceutical?

Distinguishing pharmaceuticals for human use from other medicinal products is performed by SÚKL.
Where a product is not classified by SÚKL as a pharmaceutical, SÚKL does not assess further classification of the product and in disputable cases the concerned responsible institutions (the National Institute of Public Health, the Ministry of Health, and, where applicable – SÚKL – Medical Devices Branch) should be addressed.
Those products which are not classified by SÚKL as pharmaceuticals, most often fall within the categories of dietary supplements, cosmetic products or medical devices.

Act No 79/1997 Coll., on Pharmaceuticals, imposes upon the State Institute for Drug Control the duty to decide in the case of doubts whether a product is a pharmaceutical, incl. the distinction between a medicinal product and an active substance, medicinal product subject to marketing authorisation or another product. Where doubts arise upon deciding about the nature of the product in compliance with other legal regulations, classification among pharmaceuticals shall be preferred with respect to the protection of public health (Section 9, paragraph 1, letter h).
Borderline issues are handled by the Office of borderline products and general classification for supply of the Institute.

What an applicant for marketing authorisation must comply with?

An applicant for a new marketing authorisation (the future marketing authorisation holder) must be established within the territory of the EU/EEA as well as the manufacturer(s) of  the medicinal product who are responsible for batch release.

What are the requirements governing marketing authorisation dossiers?

The requirements governing the marketing authorisation dossiers differ by the type of application and are described in detail both in Decree No 288/2004 Coll. and in SÚKL guidelines. The dossier must not be in a language other than the Czech, Slovak or English.
Reimbursement of costs for individual activities are detailed in guideline UST 29 v.2 and differ by the type of marketing authorisation.

What are the types of marketing authorisation procedures in the Czech Republic?

National procedure – a marketing authorisation of the medicinal product only in the Czech Republic, and only where the medicinal product is not authorised in any other EU country.

Mutual Recognition Procedure (MRP) – a marketing authorisation performed by the Mutual Recognition Procedure.
The country where the product is authorised by “national marketing authorisation”, will become the Reference Member State, while the other countries of the Community selected by the applicant shall be the Concerned Member States (CMS). The Reference Member State (RMS) will prepare an assessment report, which shall be evaluated by the other states within a 90-day period; and a decision on approval or rejection in their country will be issued. SÚKL participates in a number of these procedures both as a CMS and a RMS.

Decentralised procedure (DCP) – a marketing authorisation by the Mutual Recognition Procedure.
Like in  MRP, the applicant selects one country as the Reference Member State, and other selected countries of the Community are the Concerned Member States (CMS). Unlike in the MRP, the medicinal product is not authorised in the Reference Member State, but all countries within a 210-day period review the application and decide to approve it or reject it in their country. SÚKL participates also in this type of procedure both as the Reference Member State and as a Concerned Member State.

National procedures as well as MRPs are subject to approval in SÚKL. Apart from these two procedures there are also centralised procedures where the marketing authorisation procedure is not conducted in the national medicines agencies of the individual Community Member States. Products authorised via this procedure are authorised centrally by the European Medicines Agency (EMEA) in the United Kingdom and the marketing authorisation is effective on the entire territory of the EU Community.

A list of all medicinal products authorised via the centralised procedure, incl. marketing authorisations, SPCs, and package leaflets, are available from the EMEA website at: http://www.emea.europa.eu/htms/human/epar/eparintro.htm.

What is the legal background for marketing authorisation procedures?

1.      Independent/stand-alone application – an application with its own data in the preclinical and clinical sections of the dossier;

2.      Abridged application (generic application) – an application referring to modules 4 and 5 of the marketing authorisation dossier;

3.      Hybrid application – so called “last-paragraph application”;

4.      Bibliographic application – for products with well established long-term therapeutic use;

5.      Informed consent application – full reference to previously submitted documentation, e.g. a second name of the same product, etc.

The types of application are relevant for both national marketing authorisation procedures and MRPs.

What are the timelines for approving applications for marketing authorisation?

In the case of marketing authorisations conducted via the MRP, the 90-day marketing authorisation procedure in the Reference Member State is followed by a 30-day phase on the national levels in the Concerned Member States;  the Marketing Authorisation takes affect after the coming legally into force of the national Marketing Authorisation.

In the case of marketing authorisations conducted via DCP, the 210-day marketing authorisation process in the  Reference Member State is followed by a 30-day phase on the national levels in the Concerned Member States;  the Marketing Authorisation takes affect after the coming legally into force of the national Marketing Authorisation. 

For national marketing authorisation procedures, the timeline for the assessment of generic products is 150 days, for other types of national marketing authorisation procedures it is 210 days. The applicant is allowed 180 days to amend shortcomings in the dossier. This period of time is not included in the overall duration of the marketing authorisation procedure; final time of the marketing authorisation procedure is therefore often longer.