对欧洲议会和理事会条例(EU) No 1235/2010的勘误，该条例就人用药品的药物警戒，修订关于制定共同体关于批准和监管人用或兽用医药产品的程序并建立欧洲医药品管理局的条例(EC) No 726/2004，以及修订关于高级资料药品的条例(EC) No 1394/2007(OJ L 348, 31.12.2010)
技术法规类型：欧盟Eurlex法规 来源：tbtmap
EURLEX ID：32010R1235R(01)
OJ编号：OJ L 201, 27.7.2012, p. 138-138
中文标题：对欧洲议会和理事会条例(EU) No 1235/2010的勘误，该条例就人用药品的药物警戒，修订关于制定共同体关于批准和监管人用或兽用医药产品的程序并建立欧洲医药品管理局的条例(EC) No 726/2004，以及修订关于高级资料药品的条例(EC) No 1394/2007(OJ L 348, 31.12.2010)
原文标题：Corrigendum to Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products ( OJ L 348, 31.12.2010)
文件类型：二级立法 Regulation|条例
法规全文：查看欧盟官方文件
| 27.7.2012 | EN | Official Journal of the European Union | L 201/138 |
Corrigendum to Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products
( Official Journal of the European Union L 348 of 31 December 2010 )
On page 6, Article 1(7):
for:
| ‘�. | Article 16 is replaced by the following: ‘淎rticle 16 (‘� 3. The marketing authorisation holder shall ensure that the product information is kept up to date with the current scientific knowledge including the conclusions of the assessment and recommendations made public by means of the European medicines web-portal established in accordance with Article 26. 4. In order to be able to continuously assess the risk-benefit balance, the Agency may at any time ask the marketing authorisation holder to forward data demonstrating that the risk-benefit balance remains favourable. The marketing authorisation holder shall answer fully and promptly any such request. The Agency may at any time ask the marketing authorisation holder to submit a copy of the pharmacovigilance system master file. The marketing authorisation holder shall submit the copy at the latest 7 days after receipt of the request.‘�‘� |
read:
| ‘�. | In Article 16, paragraphs 1, 2 and 3 are replaced by the following: ‘淎rticle 16 (‘� 3. The marketing authorisation holder shall ensure that the product information is kept up to date with the current scientific knowledge including the conclusions of the assessment and recommendations made public by means of the European medicines web-portal established in accordance with Article 26. 3a. In order to be able to continuously assess the risk-benefit balance, the Agency may at any time ask the marketing authorisation holder to forward data demonstrating that the risk-benefit balance remains favourable. The marketing authorisation holder shall answer fully and promptly any such request. The Agency may at any time ask the marketing authorisation holder to submit a copy of the pharmacovigilance system master file. The marketing authorisation holder shall submit the copy at the latest seven days after receipt of the request.‘�‘� |
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