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Medicines Authority

Awtorità dwar il-Mediċini

 

                

                     News, Updates and Events

 

Draft Paper for Consultation: European Heads of Medicines Agencies (HMA) Strategy Paper II Read more [20.07.2010]

Information regarding the US FDA recall of McNeil Consumer Healthcare Products Read more [07.05.2010]

Information Session (Herbal Medicinal Products) Read more [04.05.2010] - Presentations uploaded

Information session (Community Pharmacy Practice) Read more [04.05.2010] - Presentations uploaded

Medicines Authority organises training with its UK counterpart.  Read more [19.01.2010]

Update on the requirement for national renewals. Read more [13.01.2010]

Update on variations legislation. Read more [01.12.2009]

The Medicines Authority awarded the FHRD HR Award. Read more [01.12.2009]

Innovative Medicines Initiative - Second Call for Proposals Read more [19.10.2009]

Medicines Authority Circular No P06/2009  Re: Use of over-the-counter cough and cold medicines in children - Update - 02.03.2009

Medicines Authority Circular No P03/2009 Re: The EMEA recommends suspension of the marketing authorisation of Raptiva (efalizumab) - 19.02.2009

Medicines Authority Circular No P11/2008 Re: The EMEA recommends the suspension of the marketing authorisation of Acomplia - 23.10.2008

Information on fee payments

Twinning Light 2008

Update on Heparin Products

Medicines Authority Circular P04/08 - Over-the-counter cough and cold medicines for children

Further capacity building at the Medicines Authority

Expression of interest for expertise to support the Medicines Authority on assessment and pharmaceutical activities related to medicinal products for human use.

Persons to carry out Maltese Translation Checks

Implementation of article 126(a) of Directive 2004/27/EC Medicines (Marketing Authorisation) Regulations - More information

Package Leaflets (PLs) and Summary of Product Characteristics (SPCs) of authorised products are now available . Click here

Medicines Authority Circular No I01/2005: Revocation of Wholesale Dealer's Licence of John Meli & Co - 21/11/2005

Medicines Authority Circular P18-2005 RE: Post-licensing requirements with respect to submission of Periodic Safety Update Reports (PSURs) for products licensed through the PMA-MA procedure.

Bank Details for the Payment of Fees

Medicines Authority Circular No P17/2005: Post-licensing requirements with respect to submission of recently approved variations or ongoing variations which are not reflected in the dossier submitted for a Marketing Authorisation  get file in pdf format

 10 September 2004. Applications for Registration of Qualified Persons (QPs).  get file in pdf format

The list of Products given a Marketing Authorisation via the Centralised Procedure can be found on the EMEA website.

Pulmicort 200 microgram/dose pMDI (Class II Medicines Recall)

   

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