Herbal Medicinal Products
Effective
regulation of herbal medicinal products is considered
necessary in order to ensure that safe products of appropriate
quality continue to be available.
Manufacturers, importers and wholesale dealers of medicinal
products containing herbal preparations need to meet the
requirements of these regulations.
Directive 2004/24/EC,
amending Directive 2001/83/EC,
which is the legislation regulating
Traditional Herbal Medicinal Products came into force on
the 30th October 2005. Herbal products falling
under the definition of 'Traditional Herbal Medicinal products'
(fulfilling all the criteria in Regulation 3 of the Herbal
Medicinal Products Regulations, 2005)
will have to be registered with the Medicines Authority prior
to being placed on the market. Further to the document
entitled
Implementation of Legislation regulating Traditional Herbal
Medicinal Products on the registration of these products
please note that:
There are two possible current and future
regulatory routes by which a herbal medicinal product can be
placed on the market.
1. Registration as Traditional Herbal
Medicinal Products: A Simplified Registration Procedure.
A seven year transitional period exists for
products that were available on the market in Malta on 30
April 2004, which means that these products need to
undergo registration by 30 April 2011.
For products that were placed on the market
after 30 April 2004, the transitional arrangements do
not exist and need to be registered to continue to be placed
on the market.
Products registered under the Simplified
Registration Procedure will need to meet specific standards of
quality and safety.
2. Marketing Authorisation Procedure
Regulated by Directive 2001/83/EC as amended.
Some herbal medicines in Malta hold a
marketing authorisation just like any other medicine.
These are required to demonstrate safety, quality and efficacy
(or effectiveness) and be accompanied by the necessary
information for safe usage.
Further information on these two routes is
available in the section on
Placing a herbal medicinal product on the Maltese Market
and legislation and guidelines that are relevant to the
registration process include:
Herbal Medicinal Product Regulations
Directive 2004/24/EC
amending Directive 2001/83/EC regulating traditional herbal
medicinal products.
Medicinal Products (Labelling and
Packaging) Regulations, 2005
Medicinal Products (Advertising)
Regulations, 2005
Pharmacovigilance Regulations, 2005
Borderline Classification Committee
Application Form
Notice to Applicants Chapter 1 Marketing
Authorisation (November 2005)
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