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Authorisation
procedure for
marketing medicinal products containing or consisting of genetically
modified organisms
(Author: M. Goossens - Last revised:
February 28, 2006
)
The general procedure for marketing authorisation of medicinal products is explained on the Web site of the EMEA (The European Agency for the Evaluation of Medicinal Products), section human medicines or veterinary medicines.
In case of a medicinal product for human use and containing or consisting of genetically modified organisms, the following articles of Regulation 726/2004/EC apply :
Article 6.2. In the case of a medicinal product containing or consisting of genetically modified organisms within the meaning of Article 2 of Directive 2001/18/EC, the application shall be accompanied by:
- a copy of the competent authorities' written consent to the deliberate release
into the environment of the genetically modified organisms for
research and development purposes where provided for by Part B
of Directive 2001/18/EC or in part B of Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of
genetically modified organisms;
- the complete technical dossier
supplying the information required by Annexes III and IV to
Directive 2001/18/EC;
- the environmental risk assessment
in accordance with the principles set out in Annex II to Directive 2001/18/EC;
- the results of any investigations performed for the purposes of research or development.
Articles 13 to 24 of Directive 2001/18/EC shall not apply to medicinal products for human use containing or consisting of genetically modified organisms.
Article 6.3. The Agency
shall ensure that the opinion of the Committee for Medicinal Products for Human Use is given within 210
days after receipt of a valid application.
.........
In the case of a medicinal product containing or consisting of genetically modified organisms, the opinion of the said Committee shall respect the environmental safety requirements laid down by Directive 2001/18/EC. During the process of evaluating applications for marketing authorizations for products containing or consisting of genetically modified organisms, the rapporteur shall carry out necessary consultations of bodies that the Community or Member States have set up in accordance with Directive 2001/18/EC.
In practice and since Directive 2001/18/EC has repealed Directive 90/220/EEC, once the application has been validated, the EMEA Secretariat informs the Competent Authorities for Directive 2001/18/EC, establishes the timetable and informs the Applicant that for Belgium part II.H of the application dossier supplying the information requested in Annexes III and IV to Directive 2001/18/EC and the environmental risk assessment in accordance with the principles set out in Annex II to Directive 2001/18 needs to be addressed to the Secretariat of the Belgian Biosafety Council. After consultation of its ad hoc experts group(s), the Belgian Biosafety Council forwards its remarks and questions to the EMEA Secretariat and to the rapporteur in charge of the dossier. The questions judged pertinent by the EMEA Committee for Human Medicinal Products (CPMP) are addressed to the applicant together with all the other questions concerning this application dossier. When the applicant has supplied answers to all the questions, the final conclusion remains with the CPMP which after having assessed the quality, safety and efficacy data provided by the applicant in support of its product, shall discuss the risk versus the benefit of the use of the product and shall recommend or not the granting of a Community Marketing Authorisation. The opinion of the EMEA Committee is made public on its web site. When the opinion is positive, the Commission Decision will normally be issued within 90 days from adoption of the opinion. As soon as authorisation is given the EMEA publishes the European Public Assessment Report of the product on its Web site. The EPAR includes the Product information leaflet and a Summary of the product characteristics in severall european languages as well as the scientific discussion and the steps taken for assessment (in english).
The same applies to veterinary medicines containing or consisting of genetically modified organisms (Article 31 of Regulation 726/2004/EC).
Click here for details about the applications which have been granted European approval.
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