NEW EUROPEAN COMMISSION REGULATION ON VARIATIONS TO THE TERMS OF MARKETING AUTHORISATION FOR MEDICINAL PRODUCTS AND ITS IMPACT ON CROATIAN LEGISLATION

被引：0

作者：

Martinac, Adrijana Ilic ^{[1
]}

Tomic, Sinisa ^{[1
]}

Simicic, Mirna ^{[2
]}

机构：

[1] Agcy Med Prod & Med Devices, Zagreb 10000, Croatia

[2] Jadran Galenski Lab DD, Rijeka, Croatia

来源：

ARHIV ZA HIGIJENU RADA I TOKSIKOLOGIJU-ARCHIVES OF INDUSTRIAL HYGIENE AND TOXICOLOGY | 2010年 / 61卷 / 03期

关键词：

efficacy; Medicinal Products Act; quality; registration documentation; safety;

D O I：

10.2478/10004-1254-61-2010-2015

中图分类号：

R1 [预防医学、卫生学];

学科分类号：

1004 ; 120402 ;

摘要：

Variations introduced to medicinal product documentation must not affect the quality, efficacy, and safety of the product Croatian Medicinal Products Act and accompanying ordinances are largely aligned with the EU regulations. The EU has now tried to simplify the issue of variations with a new Regulation, creating differences in the definition of and approach to resolving certain types of variations between Croatia and the EU These differences could hinder the approval procedure for variations in Croatia, particularly for medicines already approved in the EU Amending the Croatian Ordinance on medicines already authorised in the EU would be one way of maintaining the efficiency of the Croatian regulatory system.

引用

页码：311 / 322

页数：12

共 30 条

[1] THE MARKETING AUTHORISATION OF ADVANCED THERAPY MEDICINAL PRODUCTS UNDER THE REGULATION OF THE EUROPEAN UNION
Mahalatchimy, A.
Gilbert, L.
Delage, A.
Negre, O.
[J]. CYTOTHERAPY, 2023, 25 (06) : S160 - S161
[2] Adverse drug reactions that arise from the use of medicinal products outside the terms of the marketing authorisation
Skvrce, Nikica Mirosevic
Galic, Iva
Pacadi, Carmen
Kandzija, Neva
Mucalo, Iva
[J]. RESEARCH IN SOCIAL & ADMINISTRATIVE PHARMACY, 2020, 16 (07): : 928 - 934
[3] Ten Years of Regulation for Orphan Medicinal Products in the EU: Characteristics Associated with Marketing Authorisation
Putzeist, Michelle
Heemstra, Harald E.
Mantel-Teeuwisse, Aukje M.
Gispen, Christine C.
Hoes, Arno W.
Garcia, Jordi Llinares
Leufkens, Hubert G.
[J]. PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2011, 20 : S221 - S222
[4] Harmonised European Standards as a Basis for the Safe Use of Herbal Medicinal Products and Their Marketing Authorisation in European Union Member States
Peschel, Wieland
Alvarez, Beatriz Monedero
[J]. PHARMACEUTICAL MEDICINE, 2018, 32 (04) : 275 - 293
[5] Impact of the new European regulation on the authorisation of new oncology drugs in the European Union (EU)
Chapelin, M.
Pignatti, F.
Aronsson, B.
Saint-Raymond, A.
Le Courtois, P.
[J]. EJC SUPPLEMENTS, 2005, 3 (02): : 146 - 147
[6] New European Regulation for Clinical Trials of Medicinal Products
Lemaire, Francois
Matei, Mihaela
Juvin, Philippe
[J]. AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE, 2015, 191 (01) : 16 - 18
[7] The New Regulation of Advanced Therapy Medicinal Products in the European Union
Ruiz, Sol
[J]. MOLECULAR THERAPY, 2009, 17 : S395 - S395
[8] Notification Systems Allowing Marketing Authorisation Holders to Inform Competent Authorities About New Information Related to Their Medicinal Products
Arlett, P.
Plueschke, K.
Almeida, E.
Thi, B.
Kurz, X.
[J]. DRUG SAFETY, 2015, 38 (10) : 964 - 964
[9] Post-marketing authorisation safety and efficacy surveillance of advanced therapy medicinal products in Brazil, the European Union, the United States and Japan
Gomes, Kelly Lucy Guimaraes
da Silva, Ricardo Eccard
da Silva Junior, Joao Batista
Bosio, Cleila Guimaraes Pimenta
Novaes, Maria Rita Carvalho Garbi
[J]. CYTOTHERAPY, 2023, 25 (10) : 1113 - 1123
[10] Evolution of European Union legislation of herbal medicinal products and its transposition to national legislation in 1965-2007: case Finland
Koski, Sari M.
Laitinen-Parkkonen, Pirjo
Airaksinen, Marja
[J]. INTERNATIONAL JOURNAL OF HEALTH PLANNING AND MANAGEMENT, 2015, 30 (03): : 260 - 275

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