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Pharmacy Licence for Medicinal Products for Human Use

This application will provide an authorisation to open or keep a pharmacy for medicinal products for use in humans granted under the Medicines Act and issued by the Licensing Authority.
Qualified Person Eligibility (On a Manufacturing Importation Authorisation)

For a person to be named on a Manufacturing Importation Authorisation (MIA) as a Qualified Person (QP), s/he must be approved by the Competent Authority issuing that MIA as being eligible to be named as a QP. The Competent Authority must be satisfied that Directive 2001/83/EC (Article 49) requirements as transposed into the national legislation (Medicines Act 2003 Article 38 (1e) and Regulation 9 of L.N. 381 of 2005 as amended) are fully met.
Renewal of a Marketing Authorisation

Marketing Authorisations (MA) granted in the Community shall have an initial duration of 5 years according to Regulation 19(1) of the Marketing Authorisation Regulations (Article 24(1) of Directive 2001/83/EC, as amended). After these 5 years, the MA needs to be renewed on the basis of a re-evaluation of the risk-benefit balance. An application for renewal of a MA shall include the below documents:
Signed covering letter in paper format (if submitting through CESP);
EU application form for renewal list of all post-authorisation submissions since authorisation/last renewal;
Certificate of compliance with Good Manufacturing Practice;
Quality overview (quality expert statement);
Addendum to clinical overview (if required);
Reports of post-marketing experience (PSURs).
The renewal application should be submitted according to the EU-CTD format. All the information can be sent electronically through CESP or if on DVD/CD, these should be accompanied by a signed cover letter.
Request for Sunset Clause Exemption

Request for an exemption from the invalidation of a Marketing Authorisation.
Scientific Advice Request (SAR) or Protocol Assistance (PA)

This application will enable a discussion with the Medicines Authority about scientific matters regarding the development and licensing of medicinal products.
Transfer of a Marketing Authorisation Holder During the Authorisation Procedure

The transfer procedure must be used where the legal entity of an authorisation/registration holder is changed and the product is transferred to a new company during the authorisation procedure stage. When an authorisation is transferred during the national phase but before the granting of the marketing authorisation, the new holder must notify the Medicines Authority using Transfer Form B. Once the application is considered valid, the transfer will be processed within approximately 60 days.
Transfer of a Marketing Authorisation Holder for an Authorised Product

This application enables a company to take over responsibility from another company (different legal entity) where the application is in identical terms to the existing marketing authorisation after the marketing authorisation is already issued.
Variation to a Manufacturer's Importer's or Wholesale Dealer's Licence

This application will enable the applicant to implement changes to the manufacturer's, importer's and wholesale dealer's licences.
Variation to a Parallel Import Licence

A notification of variation should be provided to the competent agency in case of changes affecting labelling, packaging or SmPC of medicinal products imported through the parallel import process.
Variation to a Pharmacy Licence

An application for a variation relating to a pharmacy should be submitted whenever there is a change pertaining to the related activity that may or may not require an inspection.

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