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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. One can find general advice on safety of herbal
medicinal products within the
Herbal Safety advice page of this website.
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. These products
can continue to be marketed in accordance with the
requirements for these categories of products. These products
are regulated by the Malta Standards Authority.
Herbal
medicinal products, regulated by the Medicines Authority, fall
into two main categories, depending on whether they fulfil the
criteria for the definition of a traditional herbal
medicinal product or a medicinal product.
1.
Is your Herbal product a Traditional Herbal Medicinal Product
(THMP) or a Herbal Medicine (HMP)?
It is
important that you begin by establishing whether your product
is classified as a herbal medicine, traditional herbal
medicine or none. If it is not a herbal medicinal product or a
traditional herbal medicinal product, you do not have to
comply with medicines legislation (although you will have to
comply with other legislation relevant to your product e.g.
that regulating foods or cosmetics).
2.
How herbal medicines can be authorised to be placed on the
Market
If a herbal
product is classified as a medicine, there are two possible
regulatory routes by which you can legally supply your herbal
medicine. You will need to ensure that your product complies
with the necessary requirements.
2.1.
Registration as Traditional Herbal Medicinal Products: A
Simplified Registration Procedure.
Directive
2004/24/EC of the European Parliament and of the Council,
amending, as regards Traditional Herbal Medicinal Products,
Directive 2001/83/EC on the Community Code relating to
Medicinal Products for Human Use, was published on the 31
March 2004 in the Official Journal of the European Union. This
directive came into force on the 30 April 2004 throughout the
European Union, thus harmonizing the regulation of Traditional
Herbal medicinal Products. As a member state, Malta is obliged
to comply with this Directive. The directive was transposed
into Maltese legislation, as a legal notice under the
Medicines Act, 2003 -
Legal notice 379 of 2005.
Implementation will be started in 2010, and therefore a
transitional period is allowed for products currently already
on the market, that fall within the definition of a
traditional herbal medicinal product or a medicinal product.
This will allow enough time for companies to come in line with
the necessary requirements.
For new
products that are to be placed on the market after September
2010, the transitional arrangements do not exist and products
need to be registered prior to placing on the market.
Products
registered under the Traditional Herbal Medicinal Procedure
will need to meet specific standards of quality and safety.
They need to be accompanied by agreed indications, based on
traditional usage and systematic patient information allowing
the safe use of the product.
The
Committee Herbal on Medicinal Products (HMPC), which meets at
the EMA (European Medicines Agency), is finalizing a list of
monographs
HMPC Monographs and this may help in deciding on the
appropriate registration process for your product.
This list
will relate to Community Herbal monographs relevant to the
registration and authorization of Traditional Herbal Medicinal
Products throughout Europe. These monographs will provide
guidance as to the properties of these products, including
therapeutic uses, pharmaceutical forms and strengths that
would classify them as medicinal products. An applicant
seeking to register a product containing a substance on the
list in the form and for the indications as specified on the
list could then refer to this list rather than have to
demonstrate Traditional use and safety.
The
Simplified Registration Procedure can also be used for
products containing herbal medicinal products in combination
with vitamins/minerals, provided that the action of the
vitamins and minerals is ancillary to that of the herbal
active ingredient(s) regarding the specified claimed
indication.
In
accordance with the legislation, herbal substances which are
prescription only are not eligible for the simplified
procedure, and should apply for a marketing authorization.
Herbal medicinal products intended for injection will also not
be granted a registration under the simplified procedure.
Simplified registrations will be permitted for herbal
medicines that are taken orally, for external use or
inhalation.
For this
simplified registration procedure, several criteria must be
met, including evidence that the medicinal product, or a
corresponding product (having the same active ingredient or a
combination of ingredients and a similar intended purpose) has
been in medicinal use throughout a period of at least 30 years
preceding the date of application, including at least 15 years
within the Community.
Some of the
documents that will be required for traditional herbal
medicinal simplified registration include:
-
Quality
dossier covering the quality of the herbal ingredients and
the finished product
-
Bibliographic review of safety data
-
Expert
report/s on non-clinical and clinical aspects of safety
-
Expert
report/s including bibliographic or expert evidence that the
medicinal product or corresponding product has been in
medicinal use throughout a period of 30 years preceding the
date of application (including at least 15 years within the
EU)
-
any
authorization or registration obtained by the applicant in
another Member State, or in a third country, to place the
medicinal product on the market, and details of any decision
to refuse to grant an authorization or registration, whether
in the Community or a third country, and the reasons for any
such decision
-
Draft SmPC
(Summary of Product Characteristics)
-
Draft
package leaflet
-
Draft
labelling
The
Simplified Registration for THMPs cannot be used for
Homeopathic Products (regulated by Directive 2001/83/EC). For
these products the simplified procedure for homeopathic
products should be followed.
For further
information on dossier requirements for registration please
refer to this document:
Registering Herbal medicinal products - Compiling the dossier.
2.2
Marketing Authorization in accordance with Article 10a of
Directive 2001/83/EC (Well established use)
After the
introduction of the Traditional Herbal Medicinal Product
Registration Procedure, it is still possible to obtain a
marketing authorization for herbal medicines where the
required levels of safety, quality and efficacy can be
demonstrated. The existing arrangements will continue under
which herbal medicinal products (like any other medicines) may
be eligible for a full marketing authorization based on
demonstration of safety, quality and efficacy.
Registration
requirements for this type of authorization are similar to
those of other medicinal products and are subject to all the
requirements of the regulations under the Medicines Act,
2003. Herbal products that do not contain herbal preparations
or substances that would place them under the category of
medicinal products but are still presented for treating or
preventing disease may still fall within the definition of
medicinal product. Please refer to the
Guide on what is a medicinal product for more
information.
More
information on registration requirements can be obtained from
Chapter 1 Marketing Authorization (November 2005) on the
Commission website where other guidelines on the format of the
dossier, SmPC etc can also be found.
Further
information on dossier requirements for registration for both
types of registration procedure can be found in this document:
Registering Herbal medicinal products - Compiling the dossier.
3.
Deciding which regulatory route is required for your
products:
To get more
information on what is currently available on the Maltese
market, you are also kindly being requested to fill in the
Herbal Products
Sheet. Please include all your products containing
herbal preparations (even those that are not medicinal
products). Please include only products that contain herbal
preparations or substances (if they ALSO contain other
ingredients, such as vitamins or minerals, please also list
these non-herbal ingredients in the ‘Ingredients’ column. Do
NOT include products that do not contain any herbal substances
or ingredients (e.g., those solely composed of vitamins,
minerals, glucosamine, chondroitin, menthol, camphor and other
such non-herbal ingredients). This list will help the
Medicines Authority establish what is currently on the market
and which products may require registration. Products
previously notified to Malta Standards Authority (MSA) must
also be included. Products previously notified to MSA as food
supplements or cosmetics may now fall under the category of
medicinal products. Please send the sheet in excel format by
email to herbals.adm@gov.mt.
If your
products fall under the medicinal product categories described
in sections 2.1 and 2.2 above, they have to meet specific
standards of safety and quality. These products will be
assessed by the Medicines Authority and granted a product
licence or an authorization to allow them to continue to be
placed on the market. This will ensure that the public is
protected against low grade and possibly unsafe products.
A
list of plants and herbal substances that are
exclusively used in herbal medicinal products and have no use
in foods or food supplements has been compiled. All products
containing these herbal substances or preparations will need
to be registered as medicinal or traditional herbal medicinal
products to be placed on the market. Their use in food
supplements is not considered acceptable.
For these
products (with no food use) and for all the other products
containing other herbal preparations or substances that fall
under the classification of a medicinal product, a
HERBAL CLASSIFICATION FORM should be filled in
for the herbal products currently on the Maltese market that
you think may fall in the two categories above (i.e. medicinal
products). The filled in form should be sent by email to
herbals.adm@gov.mt.
It is
important to fill the form for all the herbal products that
fall within the definition of a traditional herbal and herbal
medicinal product which are on the market. A
GUIDANCE DOCUMENT has been prepared to help you
fill in the classification form.
A
self-explanatory
DECISION TREE will help you decide whether your
products fall within the definition of herbal medicinal
products or traditional herbal medicinal products.
Lists of
products will be created from these forms and these lists will
be used to compile the transitional lists including all the
products that will benefit from the derogation period for
registration. The lists will be published by the Medicines
Authority by 31 December 2010.
The products
will be verified by comparing to notification information kept
by Port Health and Malta Standards Authority. If in doubt
whether your product is a medicinal product or not, fill in
form anyway.
Failure to
comply will confirm that the distributor is not interested in
having his products on the transition list, thus not intending
to apply for a product registration and therefore, does not
intend to benefit from the derogation for the registration of
these products.
Medicinal
products that are not registered appropriately will not be
allowed on the market unless they are included in the list and
a marketing authorization or simplified registration
application is received by the Medicines Authority by December
2011. If no application form for registration is sent,
written confirmation that you are no longer interested in
placing the product on the market after 31 March 2012 should
be received by December 2011. Products for which a
registration application form is not received will not be
allowed on the market after 31 March 2012.
It is the
responsibility of the person/ company placing the product on
the market to make sure that this is done in accordance with
the required legislation.
For more
information on the regulation of herbal medicines in Malta or
any herbal related queries please contact:
Herbals Committee
Medicines
Authority, 203, Level 3, Rue D'Argens, Gzira GZR1368
Tel: +
(356) 23439177/23439185
Fax: + (356)
23439161
Email:
herbals.adm@gov.mt
Each company
placing herbal medicinal products on the market will also be
required to hold an importer’s or a wholesale dealer’s licence
issued by the Licensing Authority as well as an
authorization/product registration for each individual herbal
medicinal product on the market, as is the case with other
medicinal products (as specified in
Medicines Act, 2003 (as amended), Articles 54-65).
For more
detailed information of manufacturing, wholesale dealing,
importation of medicinal products in Malta you may access the
Inspectorate section of the website or send an email to
inspectorate.adm@gov.mt.
Important Timelines
30 September
2010
Companies to
send filled in Herbal Products Sheet and Herbal Classification
Form to Medicines Authority
1 October
2010
New herbal
medicinal products not placed on the market before 1 October
2010 must be registered before being placed on the
market
31 December
2010
Medicines
Authority publishes transition lists for medicinal products
that fall within the definition of a medicinal product or a
traditional herbal medicinal product
1 January
2011
Products
classified as herbal medicinal or traditional medicinal
products must be sold only from pharmacies. Stocks in other
retail outlets must be sold out by end March 2011
31 December
2011
Companies
must submit applications for a marketing authorisation or a
simplified THMP registration. Companies not already licensed
as importers or wholesale dealers must submit applications to
regularise these activities
31 March
2012
Only those
products for which an application is received, and
subsequently authorised, may be placed on the market after 31
March 2012.
Documents and references at a glance:
EU
Legislation: Directive
2004/24/EC of the European Parliament and of the Council,
amending, as regards Traditional Herbal Medicinal Products,
amending Directive 2001/83/EC
Maltese
legislation:
Legal Notice 379 of 2005: Herbal Medicinal Products
Regulations, 2005
Medicinal plants and herbal substances
DECISION TREE
for guidance to decide whether a product falls within the
definition of herbal medicinal product or traditional herbal
medicinal product
HERBAL PRODUCTS SHEET
HERBAL CLASSIFICATION FORM
GUIDANCE DOCUMENT to fill in the Herbal Classification
Form
European
Commission –
Herbal Medicinal Products Information
European
Medicines Agency –
Committee on Herbal Medicinal Products (HMPC)
European
Medicines Agency -
HMPC Monographs
Information Session (Herbal Medicinal Products)
Read more
[04.05.2010]
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