Consultation Meeting on Amendments to Legislation

The Kamra ta’ l-Ispizjara and other stakeholders discussed their views and opinion re three (3) important consultation documents concerning amendments to present legislation yesterday afternoon during a meeting held at the Medcines Authority.  These are:

1.Consultation Document on the amendment to Legal Notice 315 of 2006 – Medicines Authority (fees) Regulations, 2006, as regards fees related to product registration activities where malta is reference member state in the european procedures (Mutual Recognition and Decentralised Procedure)

2. Consultation Document on implementation of Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use.

3. Consultation Document on the proposed amendments to Subsidiary Legislation 458.16 (Legal Notice 279 of 2007 as amended (Pharmacy Licence Regulations, 2007) and to Subsidiary Legislation 458.49 (Legal Notice 292 of 2006 – Prescription and Dispensing Requirements Rules).

Kamra members have access to these documents which may be downloaded from the members area.  We shall keep members posted with the Kamra’s feedback re these documents in due course.

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