Polish dating eskorte sandefjordThe objective of PSUR synchronisation project is to make only one PSUR version acceptable for all EU Member States. Marketing authorisation holders of medicinal products authorised through mutual recognition procedures with CR as CMS do not have to apply for Type II variation. Web portal supplier - QCM, s. At the beginning of January , marketing authorisation holders of original medicinal products were requested to propose EU HBDs and corresponding DLPs Data lock points of their products. REBECKA HOT Oslo This results in duplicate work of both MAHs and competent authorities, which may even have negative impact on quality of the reports.
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- Marketing authorisation holders of medicinal products authorised through national or mutual recognition procedures with CR acting as RMS with DLP from October to December should apply for Type II variation before the end of
- The International birth date IBD is the date of the first marketing authorisation, the EU birth date is the date of the first authorisation in Europe. On the grounds of the above mentioned facts we apply for a waiver of cost reimbursement fees for activities performed in respect of the assessment of this application for a variation to marketing authorisation for medicinal product ……………….
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Information for marketing authorisation holders on the procedure for synchronisation of PSUR submission schemes based on EU HBD For majority of products the introduction of EU HBD means that the PSUR submission schemes need to be changed. State Institute for Drug Control Medicines Medical Devices Pharmacies Healthcare Facilities Pharmaceutical Industry Distribution SUKL.
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Thus, the same product of one marketing authorisation holder can follow different PSUR schemes in the various EU Member States. Since it is in the public interest to make changes in PSUR submission schemes on the basis of HBD, as required by the synchronisation project, we recommend that applicants submit simultaneously with the application form also a request for waiver of costs reimbursement under Section 65 2 b of the Act on Pharmaceuticals giving the reasons as quoted bellow:. Archive Webmaster Accessibility Conditions of use of web presentation services Contacts Sitemap RSS. Information on the EU Synchronisation of PSUR submission SÚKL Information for Marketing Authorisation Holders on the EU Synchronisation of PSUR submission schemes of medicinal products authorised through national, mutual recognition and decentralised procedures. EU HBD Harmonised birth date. The only exception to the above procedure applies to marketing authorisations granted through mutual recognition procedure or decentralised procedure where the Czech Republic is a Concerned Member State CMS.