Medicines (Marketing Authorisation) (S.L. 458.34)

Inhoud

1. Art. 1 Citation.
2. Art. 2 Interpretation.
3. Art. 2A List of medicinal products to be published.
4. Art. 3 Applicability.
5. Art. 4 Authorisation for placing on the market.
6. Art. 4A Derogation for products from the United Kingdom.
7. Art. 5 Grantorrenewalof marketing authorisation.
8. Art. 5A Obligations of the authorisation holder. S.L. 458.35. S.L. 458.36.
9. Art. 6 Application for radionuclide generator.
10. Art. 7 Details to be provided.
11. Art. 8 Summary of product characteristics.
12. Art. 9 Experts to formulate and sign documents.
13. Art. 10 Specificprovisions applicable to homeopathic medicinal products.
14. Art. 11 Saving.
15. Art. 12 Processing of application.
16. Art. 13 Application already under examination in a Member State.
17. Art. 14 Duties of the Authority on receiving the report.
18. Art. 15 Examination of application.
19. Art. 16 Information to holder.
20. Art. 17 Exceptional circumstances.
21. Art. 18 Duties of authorisation holder.
22. Art. 19 Validity of marketing authorisation.
23. Art. 20 Civil and criminal liability.
24. Art. 21 Refusal of marketing authorisation.
25. Art. 22 Mutualrecognition and decentralised procedure.
26. Art. 23 Referral to Committee for MedicinalProducts for Human Use.
27. Art. 24 Application for variation.
28. Art. 25 Applications to be considered in accordance with regulation(EC)No 726/2004.
29. Art. 26 Classification of medicinal products.
30. Art. 27 Medicinalproducts subject to medical prescription.
31. Art. 28 Medicinalproducts not subject to a prescription.
32. Art. 29 List of medicinal products.
33. Art. 30 Amendment of classification.
34. Art. 31 Informing the Agency of the actions taken.