New European Commission Regulation on Variations to the Terms of Marketing Authorisation for Medicinal Products and its Impact on Croatian Legislation

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New European Commission Regulation on Variations to the Terms of Marketing Authorisation for Medicinal Products and its Impact on Croatian Legislation

机译：新的欧洲委员会关于药品营销授权条款的变化及其对克罗地亚立法的影响

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《Arhiv za higijenu rada i toksikologiju》 |2010年第3期|共11页
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1. Where is Industry Getting it Wrong? A Review of Quality Concerns Raised at Day 120 by the Committee for Medicinal Products for Human Use during European Centralised Marketing Authorisation Submissions for Chemical Entity Medicinal Products [J] . John Joseph Borg, Jean-Louis Robert, George Wade, Journal of Pharmacy and Pharmaceutical Sciences . 2009,第2期

机译：行业在哪里弄错了？在欧洲集中销售化学实体药品的授权书中，人用药品委员会在第120天提出的质量问题审查
2. Harmonised European Standards as a Basis for the Safe Use of Herbal Medicinal Products and Their Marketing Authorisation in European Union Member States [J] . Wiel Peschel, Beatriz Monedero Alvarez Pharmaceutical medicine . 2018,第4期

机译：协调欧洲标准作为安全使用草药产品及其在欧盟成员国的营销授权的基础
3. Marketing Authorisation Expenses for Veterinary Medicinal Products in Northern Europe [J] . Cernickova Z., Dohnal J., Saloun J. Indian journal of pharmaceutical sciences. . 2018,第3期

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4. Existing and Potential Regulation and Legislation Impacting Absorbent Hygiene Products in Russia and the Customs Union (PPT) [C] . Sergey Vanin International Nonwovens Symposium . 2013

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5. Initial design variations of American planned towns: Short term and long term impacts on patterns of racial composition and development. [D] . Rowlee, David Donald. 2000

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6. Failures to further developing orphan medicinal products after designation granted in Europe: an analysis of marketing authorisation failures and abandoned drugs [O] . Viviana Giannuzzi, Annalisa Landi, Enrico Bosone, 2017

机译：在欧洲获得指定后未能进一步开发孤儿药产品：对销售授权失败和废弃药物的分析
7. Report drawn up on behalf of the Committeeon Agriculture on A. the proposals from the Commission of the European Communities to the Council (Doc. 1-893/83-COM(83) 548 final) for: I. a regulation amending Regulation (EEC) No. 804/68 on the common organization of the markets in milk and milk products. II. a regulation laying down general rules applying to the milk sector levy specified in Article 5(c) of Regulation (EEC) No. 804/68. III. a regulation laying down general rules applying to the milk sector levy specified in Article 5(d) of Regulation (EEC) No. 804/68. B. the proposals from the Commission of the European Communities to the Council (Doc. 1-996/83-COM(83) 611 final) for: I. a regulation amending Regulation (EEC No. 1723/81 as regards the possibility of granting aids for the use of butter in the manufacture of certain food-stuffs. II. a regulation amending Regulation (EEC) No. 1411/71 as regards the fat content of drinking milk. III. a regulation laying down general rules on the granting of aid for concentrated skimmed milk and concentrated milk for use as animal feed. IV. a regulation amending Regulation (EEC) No. 1269/79 with regard to the terms for the disposal of butter at a reduced price for direct consumption. C. the proposal from the Commission of the European Communities to the Council (Doc. 1-1113/83)-COM(83) 644 final) for a regulation amending Regulations (EEC) No. 1078/77 introducing a system of premiums for the non-marketing of milk and milk products and for the conversion of dairy herds. [O] . Woltjer E. 1984

机译：代表农业委员会编写的报告a.欧洲共同体委员会向理事会提交的建议（文件1-893 / 83-COm（83）548最终决定）：I。修订条例的规定（欧洲经济共同体））关于牛奶和奶制品市场共同组织的第804/68号。 II。规定适用于第804/68号条例（EEC）第5（c）条规定的牛奶部门征税的一般规则。 III。规定了适用于第804/68号条例（EEC）第5（d）条规定的牛奶部门征税的一般规则。 B.欧洲共同体委员会向理事会提交的提案（文件1-996 / 83-COm（83）611最终决定）：I。修订条例的规定（欧洲经济共同体第1723/81号关于可能性的规定）在制造某些食品时使用黄油的辅助手段.II。修订关于饮用牛奶脂肪含量的第1411/71号条例（EEC）的规定.III。关于授予的一般规则的规定对用作动物饲料的浓缩脱脂奶和浓缩奶的援助.IV。修订第1269/79号条例（EEC）关于以低价直接食用黄油的条款的规定。欧洲共同体委员会向理事会提交的文件（文件1-1113 / 83）-COm（83）644 final）关于修订第1078/77号条例（EEC）的法规，引入了非保险费制度销售牛奶和奶制品以及奶牛转换。

New European Commission Regulation on Variations to the Terms of Marketing Authorisation for Medicinal Products and its Impact on Croatian Legislation

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