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Consultation Document on the Transposition of Commission Directive (EU) 2017/1572 regarding the principles and guidelines of good manufacturing practice for medicinal products for human use


From: Ministry for Justice, Culture and Local Government (Medicines Authority)
​Published: ​15 January 2018
Running till:: 25 February 2018
​Last Updated: ​16 March 2018

Public Consultation Final Outcome Report.pdfPublic Consultation Final Outcome Report.pdf

Original Consultation​

1.        Background
Commission Directive 2003/94/EC applies to both medicinal products for human use and investigational medicinal products for human use.
In accordance with Article 63(1) of Regulation (EU) No 536/2014 of the European Parliament and of the Council, the Commission is empowered to adopt a delegated act laying down principles of good manufacturing practice for investigational medicinal products for human use.
References to investigational medicinal products for human use will be removed from Subsidiary legislation 458.42 in line with Directive (EU) 2017/1572.
Publication of new Legal Notice shall repeal Legal Notice 477 of 2012 titled ‘Good Manufacturing Practice in Respect of Medicinal Products, Active Substances and Investigational Medicinal Products for Human Use Regulations’
2.        Documents


Please be informed that submissions will be published on the webpage of this consultation at the end of the scoping phase. The lead Ministry has sole discretion upon the publication of comments.
Received contributions, together with the identity of the contributor, will be published on the Internet, unless the contributor objects to the publication of his/her personal data on the grounds that such publication would harm his/her legitimate interests. In this case the contribution may be published in anonymous form. Otherwise the contribution will not be published nor will, in principle, its content be taken into account.  Any objections concerning the publication of personal data should be sent to the service responsible for the consultation on the following email address:
Data Protection Statement Data Protection Act (Chapter 440)
The Data Protection Act, 2001 regulates the processing of personal data whether held electronically or in manual form. The Ministry for Social Dialogue, Consumer Affairs and Civil Liberties collects only information which is necessary for it to perform its intended functions and is set to fully comply with the Data Protection Principles as set out in the Act.  Verification of the ID number provided will take place as deemed necessary. All personal data provided will be processed according to the Data Protection Act (Cap 440).
In addition, please be aware of:
·         Disclosure under the Freedom of Information Act (Chapter 496)
As we are a public authority all documents we hold, including documents related to this public consultation process, may be released following a request to us under the Freedom of Information Act (Chap. 496), unless such request may be subject of an exemption arising from the same Act.

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