Archive for February, 2010

Updated Legislation Affecting Food Supplements

Thursday, February 4th, 2010

Directive on Nutrition Labelling 90/496/EEC and as amended by Directive 2003/120/EC, as well as the Food Supplements Directive 2002/46/EC and Commission Directive 2008/100/EC dated 28 October 2008 which also amends Council Directive 90/496/EEC on nutrition labelling for foodstuffs covering recommended daily allowances (RDAs), energy conversion factors and definitions. The amendments include a definition of fibre (for the first time in European law), the introduction of a calorific value (2 kcal/g – 8 kJ/g) for fibre and 0 kcal/g – 0 kJ/g for erythritol, and the revised table of RDAs for vitamins and minerals. Amendments are required to be implemented by 31st October 2012.

Classification of medicinal products, herbal and homeopathic medicines, food supplements and novel foods

Thursday, February 4th, 2010

Food supplements are currently regulated in Europe under the EC Food Supplements Directive 2002/46/EC, which has applied since 2005. Food supplements fall under the definition of ‘food’ under general food law. As such, in addition to the legislation which regulates food supplements specifically, food supplements must also comply with any other food law applicable to the product concerned, including general food labelling requirements. For food supplements, also nutrition and health claims must comply with Regulation (EC) No. 1924/2006. Food law places the onus for compliance on food business operators e.g. manufacturers, importers, wholesalers, retailers etc.  There are no defined legal requirements for GMP for this category. However, Good Manufacturing Practice (GMP) tends to be taken as the industry standard. There are legally defined requirements for Hazard Analysis for Critical Control Points (HACCP) based on the Food Hygiene Regulations 852/2004 and also there is the General Food Law regulation 178-2002 which places emphasis on traceability. As regards the ingredients in these products, food law works in such a way that if a product is considered to be medicinal, then it cannot be sold as a food. As regards health claims, food law prohibits properties being attributed to any food, including a food supplement, to the effect that it can treat, prevent or cure a human condition. Such claims would also make a product a ‘medicinal product’ under medicines legislation.

A novel food, unlike the term ‘food supplement’, is not a name under which a food can be marketed. ‘Novel food’ is a term used for foods which do not have an established history of use in the European Union prior to May 1997. Novel foods must undergo a safety assessment and be approved at European level before they can be placed on the market in the EU and must also meet food law obligations. A novel food catalogue has been created which contains information on foods and food ingredients that has been collected since the Novel Food Regulation entered into force.

At a European level the EMEA and at a national level the national health agencies are responsible for the regulation of medicines. The definition of ‘medicinal product’ also includes “…any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis”.  Of course GMP applies to all medicinal products.

 Alternatively, if the product is deemed to be a herbal product a “Certificate of Traditional-use Registration” (as per article 16a of Directive 2001/83/EC as amended via the Traditional Herbal Medicinal Products Directive (2004/24/EC) may apply.  Products in this category are registered under the Traditional Herbal Medicinal Products Registration Scheme and are known as traditional herbal medicines. A significant number of medicinal products despite their long tradition of use do not fulfil the requirements of a well-established medicinal use, with recognised efficacy and acceptable levels of safety and therefore cannot fulfil the requirements for a full MA as per article 8(3) for a full authorisation or article 10a for well-established use authorisation, of Directive 2001/83/EC as amended). 

 Homeopathic Medicines are distinct from other types of medicines, such as Herbal Medicines or Pharmaceutical Drugs, although they can be prepared from these sources.  This distinction comes from the methods used in their preparation as well as the principles on which they are prescribed. In 1992 the EC Directive 92/73/EEC, taking into account the unique nature of Homeopathic Medicines, (high dilution factor), made provision for a simplified registration procedure, for these medicines, to be implemented in Member States.

The Irish Medicines Board (IMB) is responsible for the classification of medicines in Ireland (except for controlled drugs and products authorised through the centralised procedure). For medicinal products, classifications include prescription (Rx) which includes renewable or non-renewable prescriptions, over the counter (OTC) or general sale (GSL). Herbal and homeopathic classifications can also apply.

European Pharmacopeia:

Thursday, February 4th, 2010

The Ph.Eur is recognised as the only official Pharmacopeia in Europe and is used for international trade. There are 19 observer countries and the World Health Organisation (WHO). It is presented in English and French. Directives 2001/83/EC, 2003/63/EC and 2001/82/EEC make mandatory the Ph.Eur monographs for quality specifications, Quality Control (QC) and terminology.  Raw material preparations, dosage forms, containers must comply with the Ph.Eur requirements where they exist. Certification is considered by regulators to be the preferred option. Harmonisation at an international level between the JP, EP and USP is progressing, though slowly. 45 monographs have been harmonised to date, though the basis for harmonisation can be cumbersome.

Named Patient and Compassionate Use

Thursday, February 4th, 2010

In Ireland the legal term is “exempt medicinal product” whilst it is referred to as  “specials” in the UK. The definition of “exempt medicinal product” means a medicinal product to which paragraph 2 of Schedule 1 to the Medicinal Product (Control of Placing on the Market) Regs2007, or any equivalent legislation in any other EEA State, applies. This is to say that Paragraph 2 of Schedule 1 specifies that Regulation 6 “shall not apply to the sale/supply of medicinal product in response to a bona fide unsolicited order, formulated in accordance with the specifications of practitioner for use by his individual patients, in order to fulfil special needs of those patients, but such sale/supply is subject to conditions in Para 3” (i.e. that the licensing requirements can be waived in this instance.)   


• S.I. 539/07 Medicinal Products (Control of Manufacture) Regulations 2007:

• S.I. 540/07 Medicinal Products (Control of Placing on the Market) Regulations 2007: