Part 11 Amendment of Part 11 (Pharmacovigilance)

1. 139Amendment of regulation 177 (application of Part and interpretation)
2. 140Amendment of regulation 180 (obligation on licensing authority to audit pharmacovigilance system)
3. 141Omission of regulation 181 (delegation of obligations under Part 11)
4. 142Amendment of regulation 182 (obligation on holder to operate a pharmacovigilance system)
5. 143Amendment of regulation 184 (obligation on holder to audit pharmacovigilance system)
6. 144Amendment of regulation 185 (recording obligations on the licensing authority)
7. 145Amendment of regulation 186 (reporting obligations on the licensing authority)
8. 146Insertion of new regulation 187A (collaboration with the World Health Organisation)
9. 147Amendment of regulation 187 (recording obligations on holders)
10. 148Amendment of regulation 188 (reporting obligations on holders)
11. 149Amendment of regulation 189 (signal detection: licensing authority obligations)
12. 150Amendment of regulation 190 (signal detection: holder obligation)
13. 151Amendment of regulation 191 (obligation on holder to submit periodic safety update reports: general requirements)
14. 152Amendment of regulation 192 (obligation to submit periodic safety reports: derogation from general requirements)
15. 153Amendment of regulation 193 (harmonisation of PSUR frequency or date of submission)
16. 154Omission of regulation 194 (responding to a single assessment of PSUR under Article 107e of the 2001 Directive)
17. 155Amendment of regulation 195 (obligation on licensing authority to assess PSURs)
18. 156Substitution of regulation 196 (urgent action)
19. 157Omission of regulation 197 (EU urgent action procedure)
20. 158Amendment of regulation 198 (post-authorisation safety studies: general provisions)
21. 159Amendment of regulation 199 (submission of draft study protocols for required studies)
22. 160Amendment of regulation 200 (amendment to study protocols for required studies)
23. 161Amendment of regulation 201 (submission and evaluation of final study reports for required studies)
24. 162Omission of regulation 202 (follow up of final study reports)
25. 163Insertion of new regulation 202A (medicinal products subject to additional monitoring)
26. 164Amendment of regulation 203 (obligations on licensing authority in relation to national medicines web-portal)
27. 165Omission of regulation 204 (obligation on licensing authority in relation to public announcements)
28. 166Amendment of regulation 205 (obligations on holders in relation to public announcements)
29. 167Insertion of regulation 205A (further obligations in respect of pharmacovigilance activities)
30. 168Insertion of new Schedule 12A (further provision as to performance of pharmacovigilance activities)
31. 169Insertion of regulation 205B (guidance in respect of good pharmacovigilance practice and post authorisation efficacy studies)
32. 170Amendment of regulation 206 (infringement notices)
33. 171Amendment of regulation 207 (offences)
34. 172Amendment of regulation 208 (false and misleading information)
35. 173Amendment of regulation 209 (penalties)
36. 174Omission of regulation 210 (offences relating to pharmacovigilance obligations under Regulation (EC) No 726/2004)
37. 175Amendment of regulation 210A (offences in relation to pharmacovigilance obligations under the Implementing Regulation)
38. 176Amendment of regulation 211 (persons liable)
39. 177Amendment of regulation 212 (transitional arrangements)
40. 178Amendment of Schedule 33 (transitional arrangements: pharmacovigilance)