H-1135 Budapest, Szabolcs utca 33.

Tel.: (1) 8869-300, General information: 1812

E-mail: info@egeszsegvonal.gov.hu

Mail: 1372 P.O. Box: 450.

Scientific Advice

Mellékhatás bejelentő

NOR keresőfelület Minőségi kifogás
magisztrális gyógyszerek

Website content concerning the obligations of MAHs in terms of pharmacovigilance has been updated

Announcement - Administrative break

Update on the requirements with regards to submitting national translations at the end of MRP/DCP

Issues on the introduction of required safety features for medicines

Change of contact e-mail address for pharmacovigilance enquiries

Information for marketing authorisation holders on change of requirements concerning DHPC submissions

eAF 1.25.0.0 version

Information about Appendix V of the product information

Information on nitrosamines for marketing authorisation holders

OGYÉI issued a temporary authorization for distribution of the product for emergency use

Guidance for the MAHs on the preparation and dissemination of DHPCs has been updated

Information on nitrosamines for Marketing Authorisation Holders before the closing date for the submission

General information on changes of notification process of food supplements, infant formulas and foods for special medical purposes

TRANSITION

2024-09

◀ 2024. Szeptember ▶

H	K	Sze	Cs	P	Szo	V
26	27	28	29	30	31	1
2	3	4	5	6	7	8
9	10	11	12	13	14	15
16	17	18	19	20	21	22
23	24	25	26	27	28	29
30	1	2	3	4	5	6

TRANSITION

From 31 January 2025 onwards sponsors are requested to transition to the legal framework of the CTR the ongoing clinical trials that are currently under the regime of the Clinical Trials Directive (CTD) and expected to be ongoing after 30 January 2025.

Detailes:

EudraLex - Volume 10 - Clinical trials guidelines:

Guidance for the Transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation

Last updated: 2024.04.22 13:28

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