Legislation for Consultation
Consultation: 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. Read More. [15.01.2018]
Consultation: Consultation Document on the Special Procedure (Penalties in Respect of the Medicines Act) (Amendement) Regulations. Read More. [18.04.2016]
Consultation: Consultation Document on the Pharmacy Opening Hours (Amendment) Rules, 2015. Read More. [11.02.2015]
Consultation: Consultation Document on the Guidance Notes for Pharmaceutical Companies on Pharmacovigilance Obligations for Medicinal Products for Human use version 3.05. Read More. [06.01.2015]
Consultation: Consultation Document on Pharmacy Licence (Transfer) Regulations and the amendment of the Pharmacy Licence Regulations. Read More. [12.08.2014]
Consultation: Consultation Document on the amendments of Legal Notice 437 of 2004 - Parallel Importation of Medicinal Products Regulations. Read More.
Consultation: Consultation Document on the Transposition of the Pharmacovigilance Directive 26/2012/EU. Read More.
Consultation:EU Commission Public Consultation on "Introduction of fees to be charged by the EMA for Pharmacovigilance". Read More. [28.06.2012]
Consultation: Consultation Document on the Transposition of the Falsified Medicines Directive. Read More [19.06.2012]
Consultation: Amendment to Subsidiary Legislation 458.14 (Control of Advertising of Medicinals Regulations) and Subsidiary Legislation 31.24 (Oral Retinoid Medicinal Preparations Regulations) Read more.
Consultation: Consultation Document on the Prescription and Dispensing Requirements. Read More. [20.04.2012]
Consultation: Consultation Document on the fees for Reference Member State Activities. Read More. [20.4.2012]
Consultation: Implementation of Directive 2010/84/EU on pharmacovigilance. Read more. [18.04.2012]
Public Consultations of the European Commission - DG Enterprise and Industry - Pharmaceuticals
Consultation: Variations Legal Notice Read more [07.01.2011]
Consultation: Concept paper on the revision of the 'Clinical Trials Directive' 2001/20/EC. Covering Letter Concept Paper [10.05.2011]
EC Consultation: Public Consultation on implementing measures for pharmacovigilance. Circular. Paper. [16.09.2011]
EC Consultation: European Commission Public consultation paper on the review of Regulation (EC) 1234/2008 to the handling of variations to purely national marketing authorisations. Circular | Paper [11.10.2011]
Consultation: Regulation for Medicines You can Trust. Invitation l Directive 2010/84/EU l Q&A on Pharmacovigilance Directive l Directive 2011/62/EU l Q&A on Falsified Medicines Directive [19.09.2011]
Circular MA 15/12: Public Consultations on Implementing or Delegated Acts issued under Directive 2011/62/EU of the European Parliament and of the Council amending Directive 2001/83/EC as regards the prevention of tbe entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source. available at http://www.medicinesauthority.gov.mt/inspcirculars.htm using the same format as the others