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126a Notification of Variation (Malta Medicines Authority)

Following the issue of the 126a authorisation, the Authorisation holder must notify the Medicines Authority of any changes to the authorised product, which have been approved in the Member State (EU/EEA country of source) that will affect the details on the authorisation document and/or the product information.
Adverse Drug Reaction and Medication Error Report

An Adverse Drug Reaction (ADR) is a response to a medicinal product which is noxious and unintended. This includes side effects resulting from the authorised use of a medicinal product at normal doses, medication errors, off-label use and the misuse and abuse of medicinal products.
The information on side effects helps in enhancing the safety of products as the Medicines Authority and the product's manufacturer will have a more complete and accurate picture of the experience patients are having with their medicines.
Medicine users or their relatives can report side effects directly to the Medicines Authority. Healthcare professionals are encouraged to report all ADRs and medication errors to the Medicines Authority. For the scope of this reporting system, medication errors that require reporting to the Medicines Authority are those which are related to the use of medicinal products.
Advertised Medicinal Product Complaint Form

This application enables the evaluation and investigation of a complaint regarding an advertisement for a medicinal product for human use.
Application for a Licence in accordance with the Production of Cannabis for Medicinal and Research Purposes Act

The Malta Medicines Authority reviews applications for the granting of Good Manufacturing Practice certification and/or licencing in accordance with the Production of Cannabis for Medicinal and Research Purposes Act (Cap. 578 of the Laws of Malta).
Application for a Variation to a Licence Issued in Accordance with the Production of Cannabis for Medicinal and Research Purposes Act

The Malta Medicines Authority reviews applications for variation(s) to a licence issued in accordance with the Production of Cannabis for Medicinal and Research Purposes Act (Cap. 578 of the Laws of Malta).
Authorisation for a Medicinal Product on the basis of article 126(a) of Directive 2001/83/EC

This authorisation procedure is being applied mainly to cover the public health need when there are problems with availability and access. An authorisation is granted in accordance with Regulation 4(2) of the Medicines (Marketing Authorisation) Regulations (Subsidiary Legislation 458.34), under the Medicines Act, 2003 (Chapter 458 of the Laws of Malta). The authorisation is valid for a maximum of 3 years.
Batch Specific Request (Medicines Authority)

The Malta Medicines Authority may consider a batch-specific request application from a Marketing Authorisation Holder (MAH) in order to ensure the continued availability of a medicine on the Maltese market.
Certificate of a Pharmaceutical Product

The Medicines Authority issues Certificates of a Pharmaceutical Product (CPP) on request to assist exporters of medicinal products to satisfy the import requirements of other countries. The format of the certificates complies with that specified by the World Health Organisation (WHO).
Certificate of Good Manufacturing Practice

All medicinal products for human use manufactured or imported into Malta and the EU are to be manufactured in accordance with the principles and guidelines of Good Manufacturing Practice (GMP) concerning both production and quality control.
Classification of a Borderline Product

A borderline classification form should be requested to authorise products that do not clearly fall under the definition of a medicinal product as per Medicines Act, Act III of 2003.

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