TRACE e-Gov Portal

Title	Description
Consideration of a Medicinal Product to be Covered by the Government Formulatory List	Form is to be filled in by any of the marketing authorisation holders (MAHs) or their representative local agents, when making a request for new pharmaceutical products to be considered for inclusion on to the Government Formulary List. This form also needs to be filled in for those items which are already available on the formulary but for which a new indication is being considered. All the products have to be licensed for use in the Maltese market and the indications must be in line with the entitlement procedure for free medicines that are currently in place.
Organ Donation - Registering your Wish	A form to register one's wish to donate organs after one's death.
126a New Application/Renewal (Medicines (Marketing Authorisation) Regulations)	Application of authorisation/renewal in line with regulation 4(2) of the Medicines (Marketing Authorisation) Regulations, in accordance with article 126(a) of Directive 2001/83/EC.
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.
Authorisation for Communication or Signing On Behalf of the Authorisation Holder	The letter is to be filled in by the Marketing Authorisation Holder authorising a third party to communicate on their behalf. The letter can be revoked at any time with 1 month prior notice, in writing and sent by registered mail to the Medicines Authority.
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 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 Form for a Herbal Medicinal Product	Effective regulation of herbal medicinal products is considered necessary in order to ensure that safe products of appropriate quality continue to be available. Herbal medicinal products are medicines and therefore they are likely to have an effect on the body and should be used with care. Manufacturers, importers and wholesale dealers of medicinal products containing herbal preparations and substances need to meet the requirements of current regulations on herbal medicinal products. While many herbal products are medicines, others are not, and so do not require a registration as medicinal products. There are a number of herbal ingredients that have accepted usage in a range of different categories besides medicines, including food, cosmetics or general consumer products. Herbal ingredients classified as medicinal are regulated by the Medicines Authority while herbal ingredients not classified as medicinal are regulated by the Malta Competition and Consumer Affairs Authority.
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.
Importation and/or Wholesale Distribution of Cannabis Based Products or Synthetic Cannabinoid Products in accordance with the Medicines Act and the Drug Dependence (Treatment not Imprisonment) Act	The Malta Medicines Authority reviews applications for the importation and/or wholesale distribution of cannabis based products or synthetic cannabinoid products in Malta, in line with the requirements set out in the Drug Dependence, (Treatment not Imprisonment) Act, as amended.
Marketing Authorisation for a Medicinal Product	This authorisation procedure is being applied mainly to cover the public health need created by the lack of applications for Marketing Authorisations for products which were on the derogation list and for products which were authorised in the period between the publication of the derogation list and the date of accession. 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 5 years. A renewal application should be submitted at least 6 months before the end of validity of the authorisation.
Medicinal Clinical Trials	Clinical trials are performed to find out how a medicine works, what side effects it causes and how it is metabolised by the body. Trials are conducted on new medicines and at times using medicines that are already on the market in Malta. Clinical trials refer to any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more Investigational Medicinal Products (IMP). They are also used to identify any adverse reactions to one or more IMPs, and/or to study absorption, distribution, metabolism and excretion of one or more IMPs with the object of ascertaining their safety and/or efficacy. The legal framework for clinical trials with medicinal products for human use is set out in the Clinical Trials Regulations (Subsidiary legislation 458.43) implementing the European Clinical Trials Directive 2001/20/EC.
Medicinal Product Quality Defect Form	Marketing Authorisation Holders (MAHs) or their local representatives, medical profession, wholesalers, pharmacies and patients are required to report to the Medicines Authority any defect in a product, which might necessitate a recall or cause a restriction in supply of a medicinal product, including those manufactured solely for export.
Notification of Changes to Labelling and Package Leaflets in Accordance with Article 61(3)	Notification of changes to labelling and package leaflets.
Parallel Import New Application/Parallel Import Renewal	A parallel import licence is granted for medicinal products which have a Marketing Authorisation (MA) in Malta. Once issued, it is valid for 5 years. A renewal application must be submitted at least 6 months before the expiry date.
Parallel Importation of Medicinal Products for Which Marketing Authorisations Have Already Been Granted	Parallel importation is the importation from an EU Member State or a country within the European Economic Area of a medicinal product, which has a Marketing Authorisation (MA) in Malta. The importer may be someone other than the importer appointed by the MA holder of the product on the Maltese market. The medicinal product may then be parallel imported in Malta provided that the importer obtains a licence to market the product. A parallel import licence is granted only for parallel imported medicinal products that fulfil the required criteria. A Parallel Import Licence is granted for a maximum of 5 years, at which time the licence must be renewed. A renewal application must be submitted at least 6 months before the expiry date such that the parallel import licence is renewed on time.
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.
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.
Wholesale Dealer's Licence for Medicinal Products for Human Use	Wholesale dealers will be granted a licence to distribute medicinal products for human use.

Malta

Healthcare

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