Product authorisation

Applications to establish MRLs for new pharmacologically active substances must be submitted to the European Medicines Agency (EMEA) at least 6 months in advance of an application for a marketing authorisation. In order to avoid delays, manufacturers are advised to submit an application once all the necessary data are available, as a product authorisation carmot be granted unless established MRLs are in place. The EMEA should be notified of the intent to submit an application 3 to 4 months in advance of the anticipated date, so that a Rapporteur and Co-Rapporteur can be appointed from among the members of the Committee for Veterinary Medicinal Products (CVMP). 

Other biocidal products (i.e. antifouling products) Authorisations that have been given have to be mutually recognised by all EU Member States. 

Patent protection under general law usually lasts for up to around 20 years. This creates a difficulty in relation to medicinal products, as it can take some 12 years for the products to undergo research, development, the extensive clinical trials that are required in order to obtain a marketing authorisation and the authorisation process itself. These steps are also extremely expensive. The amount of time that remains during which the patent holder can exploit his patent and recoup his massive investment can be severely curtailed in relation to medicinal products. For this reason, the European Community has provided a form of additional patent-related protection for medicinal products authorised within the European Community, by means of a Supplementary Protection Certificate. A patent holder may apply for a certificate that takes effect at the end of the term of the basic patent, for a period equal to the period that elapsed between the date on which the application for the basic patent was lodged and the date of the first authorisation to place a product derived from the patent on the market in the Community, reduced by a period of 5 years. The maximum duration of the certificate is 5 years. The certificate applies to all medicinal products derived from the basic patent, but the additional time that can be obtained under the SPC is calculated in relation to the first product derived from the patent, authorised in the EU. 

Conduct of Pharmacovigilance for Medicinal Products authorised through the mutual recognition procedure EMEA June 1997. 

This guideline lays down the roles and responsibilities of the MAH and of the national competent authorities in respect of the products authorised through the national procedures (including the mutual recognition procedure). Also defined are the roles and responsibilities of the Reference Member States (for mutual recognition products) and of the rapporteur and EMEA for centrally approved products. The role and responsibilities of the MAH include having a named, qualified person responsible for pharmacovigilance at the EU level, and there may be a need for an additional named person at the national level when this is required. 

Costs In the early stages the active substance producers will be pre-occupied with the inordinate complexity and costs of dossier preparation. As active substances enter onto Annex 1 the formulators will then start taking on testing costs/industry charges associated with biocidal product authorisation. Competition will be distorted as many SMEs will not be in a position to absorb these costs. Inevitably much of these costs will be passed onto the consumer. 

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This would apply to product restrictions or licensing schemes that do not significantly affect the functioning of the single market, for example, processes and products authorised for water treatment processes (e.g., [487]). 

In Ireland the term marketing authorisation (MA) is not a legal term the equivalent is product authorisation . Thus, product authorisation is used when specifically referring to Irish activities. For European and general purposes, the term MA is used. 

An applicant for a Product Authorisation should supply a dossier as set out in The Rules Governing Medicinal Products in Europe Volume II-Notice to Applicants. This sets out in detail what the required elements of the dossier are. 

In line with Article 14 of Decree-Law No. 72/91 of February 8, as amended by Decree-Law No. 272/ 95 of October 23 the rules applying to variations to the terms of MAs of medicinal products authorised under the national procedure are hereby set out. This is made in agreement and harmony with the Community rules governing the same variations under the decentralised procedure. 

Information must be capable of substantiation. Such substantiation need not be provided, however, in relation to the validity of indications approved in the product authorisation. 

Methods of promotion must never be such as to bring discredit upon, or reduce confidence in, the pharmaceutical industry. The promotion of a medicinal product must be consistent with the terms of the product authorisation. The following apply ... 

All promotional material issued by a product authorisation holder, or with his or her authority, must be consistent with the requirements of this code. 

Conduct of Pharmacovigilance for medicinal products Authorised through the Mutual Recognition Procedure (Rev 1)... 

Receive all relevant information about suspected adverse reactions to medicinal products authorised by the centralized procedure. 

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