FarmavitaR+

1. Counterfeit of medical products
(Regulatory Affairs/EMEA)

... trafficking thereof as well as the falsification of documents linked to medical products. In addition, they cover the manufacturing and supplying of medical products without authorisation. The convention ...

2. News-Bulgarian Drug Agency
(Regulatory Affairs/European Union)

... provided, aiming an initial evaluation of the applicants. Template for the data necessary is available in the section "Marketing Authorization of Medicinal Products/Announcement". Documents specified ...

3. NMA of Romania News Flash
(Regulatory Affairs/European Union)

... number (mobile telephone number included) - fax number - e-mail address Appointment letters are to be delivered by mail or submitted at the Documents, Samples Admissions Bureau within the timetable ...

4. eCTD
(eSubmissions/eSubmissions)

... and the ability to repurpose the same clinical trial data and documents for various regional requirements. This in turn speeds up the marketing approval process, increasing the opportunity to bring in ...

5. Administrative Fees - The Czech R.
(Regulatory Affairs/European Union)

... of a counterpart, copy, photocopy or extracts from official documents, indexes and registries, books, records, documentary files or other written and picture documentation 50.00 CZK For ...

6. Readability (QRD) Testing
(Regulatory Affairs/General Gulielines)

... totally clear how readable a leaflet has to be. One thing is clear and that is that leaflets have to be written conform the standards that the Quality Review of Documents (QRD) group of the European ...

7. World's largest patent database now online
(Regulatory Affairs/Other issues)

World's largest patent database is now online More than 63 million patent documents from 80 patent organisations worldwide can be searched via the International Patent Documentation Data Base, (INPADOCDB). ...

8. Romania - specific requirements
(Regulatory Affairs/European Union)

... site   - …………………. ……………….. 13 In separate folder 14 For all sites involved in the process, requested only if the GMP statement is not included in the Assessment Report. All documents ...

9. Management Practice
(QA and GMP/GMP/GLP/GCP/GDP)

... manufacturers the freedom to design their own solution on how to meet those needs.  Standardized protocols allow computers from different vendors to "talk" to each other. Standardized documents speed up ...

10. eCTD viewer/validator
(Regulatory Affairs/General Gulielines)

...  Tabbed Document Viewer: Open multiple documents simultaneously.    ...