Obtaining a marketing authorisation
In accordance with European legislation, medicinal products must obtain marketing authorisation prior to their placement on the market. The procedure for granting marketing authorisation starts with an application submitted by a legal entity or natural person established in the EEA.
Marketing authorisation may be obtained via:
- national procedure;
- mutual recognition procedure or decentralised procedure, or
- centralised procedure.
Application for obtaining a marketing authorisation must be in the form of a common technical document (CTD) that contains the following five modules:
- Module 1: administrative data including information on the medicinal product (Summary of product characteristics – SmPC, Patient information leaflet – PIL and labelling);
- Module 2: summarised information on the quality, safety and efficacy of the medicinal product;
- Module 3: data on the quality;
- Module 4: data on the safety; and
- Module 5: data on the efficacy of the medicinal product.
The form and content of the modules and features for certain types of applications and medicinal products are described in detail in Annex I to Directive 2001/83/EC, as amended.
Marketing authorisation for medicinal products is generally issued for a period of five years.
Maintenance of a marketing authorisation
After obtaining marketing authorisation for a medicinal product, the holder must maintain the marketing authorisation, which includes variations to the terms of marketing authorisation and renewal of marketing authorisation.
Variations to the terms of a marketing authorisation are defined in the Article 62 of the Act, which stipulates that the marketing authorisation holder must take into account scientific and technical progress and implement any necessary changes. The authority responsible for medicinal products must be notified of any new information that could impact the variation of a marketing authorisation or a change in the medicinal product documentation.
Renewal of a marketing authorisation is defined in the Article 63 of the Act, which stipulates that the validity of marketing authorisation may be renewed after five years have elapsed on the basis of an application for marketing authorisation renewal and reassessment of the risk-benefit ratio of the medicinal product. Once the marketing authorisation has been renewed for the first time, it is generally valid for an unlimited period, unless the competent authority for medicinal products decides, in the interest of public health protection, that another renewal is necessary.
Transfer of a marketing authorisation
Transfer of a marketing authorisation is defined in Article 70 of the Act, which provides that the marketing authorisation holder may transfer the marketing authorisation to another legal entity or natural person who fulfils the conditions set out in the Act.
Cessation of validity of a marketing authorisation
Marketing authorisation shall cease to be valid pursuant to Articles 61 and 66 of the Act, ex officio or at the request of the medicinal product marketing authorisation holder.