consult2deliver limited believe innovative ideas and concepts need pragmatic solutions. Our understanding of the current regulations ensures delivery of a regulatory strategy for your project.
We use our knowledge and expertise to help guide our clients through the regulatory labyrinths, to develop the right clinical and regulatory strategy for you and your project. It is hard to determine ‘Where does my project fit’? Is it a:-
- Borderline Product
Borderline products require careful evaluation to decide into what legal category they will fall i.e. will the product be considered as a medicine or not.
Sometimes it is hard to determine ‘Where does my idea/product fit’? It may not ‘fit’ in an established framework or legal category and be considered a borderline product. Such concepts are confirmed through dialogue with appropriate agencies.
- Botanical Product
Botanicals and derived preparations made from plants, algae, fungi or lichens are widely available on the EU market in the form of food supplements eg ginkgo, garlic, St. John’s Wort and ginseng. These are labelled as natural foods and a variety of claims are made regarding possible health benefits. While most of these products have a long history of use in Europe, some concerns exist with regard to safety and quality. There is not a central regulatory process for the use of botanicals and derived preparations in food. These products must comply with the general requirements set out in the Regulation of food law.
- Cosmetic Product
A new regulation came into effect 11 July 2013 for cosmetics within Europe. Briefly these changes reflect the need to strengthen safety requirements (mandatory safety reports prior to launch and labelling of nano materials included in product) and definition of a responsible person (responsibilities for marketing and reporting serious side effects). A cosmetic can be defined as:
“any substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition.”
- Food Supplement
Food Supplements must comply with Food Law, which is based on a different legal basis compared to pharmaceutical medicines.Food Supplements can list health claims on labels and in advertising where a relationship has been proven between consumption of a food and health.
In Europe claims for food/food supplements are covered by the Nutrition and Health Claims Regulation. This came into effect from July 2007. The aim of this legislation was to create a harmonised list of permitted nutrition and health claims that can be used by manufacturers across Europe, to protect the consumer from false practice. The transition period for all negative claims to be removed from pack copy for food supplements began 14 Dec 2012, with a 6 month transition period. As the transition period has elapsed only new stock with health claims on the list will be permitted for use in the European Union (EU). The European Food Safety Agency (EFSA) based in Parma, Italy; are responsible for the assessment and management of the Nutrition and Health Claims Regulation.
- Human Medicinal Product
All medicines legislation is controlled in Europe by 2001/83/EC Directive. It defines a medicinal product as: ‘Any substance or combination of substances presented for treating or preventing disease in human beings or animals’. Or ‘Any substance or combination of substances which may be administered to human beings or animals with a view to making a diagnosis or to restoring, correcting or modifying physiological functions in human beings or animals is likewise considered a medicinal product’.
Traditional herbal medicinal products and homeopathic medicinal products are the subject of additional specific EU legislation. They are considered to be medicines. All medicines must be registered with the appropriate government Health Authority and receive a Marketing Authorisation or Traditional Herbal Medicine Registration. The medicine can then be made available to the public, either with or without a prescription as appropriate.
- Medical Device
A medical device is defined as
‘Any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
- Diagnosis, prevention, monitoring, treatment, or alleviation of disease
- Diagnosis, monitoring, treatment, alleviation of, or compensation for an injury or handicap
- Investigation, replacement, or modification of the anatomy or of a physiological process
- Control of conception’
In the EU, all medical devices must be identified with the CE mark.
There are four classifications of medical devices in the European Union ranging from low to high risk:-
- Class I
- Class IIa
- Class IIb
- Class III
- Novel Food
For a compound/substance to NOT be considered a novel food, it needs to have had a history of “significant” consumption in the European Union prior to 15 May 1997. Any food or food ingredient that falls outside of this definition must be authorised according to the Novel Food legislation, Regulation (EC) No 258/97.
consult2deliver can provide clients with an overview of the novel food process and those foods already approved within Europe.The approach taken in the USA is similar but different; we can provide an overview to understand this market.
- Orphan Drug
An orphan drug is a medicinal product that has been developed specifically to treat a rare medical condition, i.e. an orphan disease. Differences exist between the EU and USA orphan drug approval process, though harmonisation between the two is in development.There are incentives for companies to develop orphan drug, with respect to scientific advice and fee reductions. However a number of criteria must be met to qualify for orphan drug designation.
- it must be intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating;
- the prevalence of the condition in the EU must not be more than 5 in 10,000 or it must be unlikely that marketing of the medicine would generate sufficient returns to justify the investment needed for its development;
- no satisfactory method of diagnosis, prevention or treatment of the condition concerned can be authorised, or, if such a method exists, the medicine must be of significant benefit to those affected by the condition.
Orphan drug status granted by the European Commission gives marketing exclusivity in the EU for 10 years after approval.
- Reclassification of Legal Status
UK legislation recognises three legal categories of medicines:
- POM (Prescription Only Medicines): may only be prescribed by a doctor
- P (Pharmacy Medicine): available in a pharmacy without prescription, under the supervision of a pharmacist
- GSL (General Sales List Medicines): on general sale.
The legal status of medicine can be switched, commonly from either a POM to P medicine or a P to GSL medicine. This is known as reclassification.
If there is sufficient evidence of safety, a POM medicine may be reclassified for sale or supply under the supervision of a pharmacist (P). Pharmacy medicines which have been safely used for several years may be suitable for general sale and may be reclassified as GSL.
POM, P, and GSL versions of the same product require different brand names. The exception where the same brand name can be used is if the change in legal supply status is due only to a difference in pack size.
The first switch POM to P switch in the UK was made to oral ibuprofen in 1983
There are clear guidelines issued by MHRA/EMA as the conditions a product must meet in order to be suitable for reclassification and the data required if such an application is to be made. consult2deliver can assist in the creation of a strategy and preparation of these submissions.
- Traditional Herbal Medicinal Product
Herbal medicines are regulated in Europe via the Traditional Herbal Medicines Directive (THMPD). Historically herbal medicines in the UK were sold and marketed under Section 12(1) of the Medicines Act. A seven year transition period to regulate herbals in line with the THMPD in the UK ended 30 April 2011. Products placed on the market before this date, are permitted sell through of existing stock. The MHRA have just ended a public consultation proposing this sell through period ends 31 Dec 2013. This will permit enforcement of the THMPD on traders who continue to sell herbal medicinal products without appropriate authorisation. In the UK more than 200 herbal products have been granted Traditional Herbal Remedy (THR) status. All THRs must comply with same requirements of safety quality and efficacy used to assess human medicines, but must be able to provide evidence of traditional use for more than 30 years (at least 15 within Europe).
- Veterinary Medicinal Product
Animal medicines legislation is controlled by European Directives & Regulations. There many similarities in the process of obtaining and maintaining an authorisation for veterinary medicines compared to Human medicines. A veterinary medicinal product is either a substance or combination of substances presented as having properties for treating or preventing disease in animals; or any substance or combination of substances that may be used in, or administered to, animals with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
A veterinary medicinal product cannot be marketed unless it has been granted a marketing authorisation by the authorised agency.
The regulatory authority in the UK for Veterinary medicines is the Veterinary Medicines Directorate (VMD).
Through regulatory evaluation, using our expertise, we can provide a strategy framework that enables our clients or investors to understand the challenges of the development programme for their project.
Determination of a regulatory strategy at the beginning of a development cycle is time well spent. A robust regulatory strategy is essential for demonstrating competence to employees, share holders and investors. Starting with the end in mind ensures consistent delivery throughout the development programme.