Regulation of cosmetic products vs. medicinal products

Regulation of cosmetic products vs. medicinal products

Today’s article is about the regulation of cosmetic and medicinal products. The EU regulations and directives (specifically Article 2 (1) (a) of Regulation 1223/2009) show that ‘cosmetic product’ means any substance or mixture intended to be placed in contact with the 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, protect­ ing them, keeping them in good condition or correcting body odours. This definition is also complemented by the negative definition contained in Article 2 (2). (a) according to which: a substance or mixture intended to be ingested, inhaled, injected or implanted into the human body shall not be considered to be a cosmetic product.

On the other hand, authorized medicinal products must comply with the definition of medicinal product contained in Section 2 (1) of the Act on Pharmaceuticals:

A medicinal product means:

(a) a substance or combination of substances presented as having therapeutic or preventive properties in the case of human or animal diseases; or

            (b) a substance or combination of substances which may be used by or ingested by humans, or used by or ingested by animals, either to restore, modify or affect physiological functions through pharmacological, immunological or metabolic action or to make a medical diagnosis.

But what about the health claim for cosmetic products?

Cosmetic products cannot use claims related to medicinal, veterinary or biocidal products or medical devices. Therefore, if a manufacturer or vendor wants to use the claims reserved for another product category, he or she can request a change in registration and product classification for that category. Not only the rules of registration differ across product categories, but also its complexity and the financial costs associated with it.

So what are the general procedures for classifying a medicinal product?

At the outset, it is necessary to define the basic starting points on which the relevant part of the legislation is based. The following rules should be kept in mind in any classification procedures:

• The protection of public health must be the starting point for any practice in this field. This conclusion follows from the purpose of the Medicines Act and Directive 2001/83 / EC constitutes the basic basis for any interpretation and application of legislation relating to pharmaceuticals. In the given area of regulation, other interests cannot be prioritized over the protection of public health, since human life is a value valued above all else in the rule of law.

• In one State, two products containing the same substance and the same mechanism of action cannot be assigned to two different categories. It should be noted, however, that the EU Court of Justice has established an exception to this general rule – it is therefore possible for two identical products to be on the market in two categories, but such a situation must be adequately justified by the characteristics and nature of both products.

• A product classification carried out by another Member State is not binding on the Czech Republic without further notice. Thus, in another Member State, a product may be classified as a foodstuff, but in the Czech Republic it would be recognized as having the characteristics of a medicinal product.

• As a rule, authorized medicinal products comply with the definition of medicinal product contained in Section 2 (1) of the Act on Pharmaceuticals. This conclusion is essential for any systematic approach in the field. Registration procedure is a complex process, often taking place jointly for several Member States of the European Union, in which the quality, efficacy and safety of medicinal products are assessed. Consequently, the results of such proceedings cannot be called into question in proceedings under § 13 para. h) of the Act on Pharmaceuticals.

• Decision in Proceedings pursuant to Section 13, Para. h) of the Act on Pharmaceuticals has a declaratory nature. The product does not become a medicinal product by the legal authority of the State Institute for Drug Control that it is a medicinal product, but only when it meets the characteristics of a medicinal product constituting its definition. A decision issued by the Institute is thus a declaratory decision. That conclusion follows from the very definition of medicinal preparation, since it is defined as a product which is presented or operated in a certain way, not as a product decided on (Article 2 (1) of the Act on Pharmaceuticals). There are a number of medicines that do not need to be authorized, so their nature is not authoritatively decided. However, in case of doubt as to the nature of the product, the Institute shall have the power to decide whether it is a medicinal product, an active substance, a medicinal product subject to authorization, a homeopathic product or another product, on request or on its own initiative. If it is not a medicinal product, further classification of the product is no longer assessed by the Institute, as it is not subject-matter relevant.

So what about registration?

• Where does the registration take place?

Veterinary medicinal products are dealt with by the Institute for State Control of Veterinary Biologicals and Drugs – www.uskvbl.cz. The distinction between medicinal products for human use and other products is dealt with by the State Institute for Drug Control (hereinafter as “SUKL”).

• What conditions must a company seeking registration meet?

The applicant for a new marketing authorization (the later marketing authorization holder) must have its registered office in the EU / EEA as well as the manufacturer or. the manufacturers of the medicinal product responsible for batch release.

• What are the registration dossier requirements?

The requirements for the registration dossier vary according to the type of application and are described in detail both in the Decree No.228 / 2008 Coll. and in the SUKL guidelines. Documentation must not be in other than Czech, Slovak or English language. The reimbursement of costs for individual registration operations is given in the UST 29 (current version) guideline and varies according to the type of registration.

• What are the types of registrations in the Czech Republic?

1. a) National marketing authorization – marketing authorization of a medicinal product only in the Czech Republic and only if the medicinal product is not authorized in another EU country.

1. b) MRP registration – mutual recognition procedure – the country in which the product is authorized “nationally” becomes the reference member state (RMS), the other Community states selected by the applicant are concerned (CMS, concerned member state). The Reference State draws up an evaluation report and the other States assess it during the 90 day procedure. In the absence of any serious comments from the States concerned, a positive decision shall be issued which shall be recognized by all States concerned. SUKL is involved in many of these procedures, both as a reference and as a state.

(c) Decentralized procedure (DCP) – registration by the mutual recognition procedure. As in the MRP procedure, one Member State is chosen as the reference member state (RMS) by the applicant, the other selected members are Community Member States (CMS). Unlike MRP, a medicinal product is not authorized in the reference country. All States will consider the application during the 210-day procedure and, unless there are serious comments, the Reference State issues a positive decision, which is recognized by all States concerned. Also in this procedure SÚKL participates in procedures, both as a reference and as a Member State.

National and MRP and DCP registrations are subject to SUKL approval. In addition to these two processes, there are also centralized marketing authorizations, which do not take place in the national medicines agencies in each Member State of the Community. The products authorized by this procedure are centrally authorized by the European Medicines Agency (EMA) in the UK and are valid throughout the EU.

A list of all authorized medicinal products through the centralized procedure including the marketing authorization, SPC, package leaflet is available on the EMA website.

Which products are not subject to marketing authorization?

Pursuant to Act No. 378/2007 Coll. On pharmaceuticals Section 25 (2) The following shall not be subject to registration:

1. a) medicinal products prepared in a pharmacy or at workplaces where it is possible to prepare medicinal products pursuant to Section 79

1. by individual prescription,

2. in accordance with the Czech Pharmacopoeia or on the basis of a technological regulation and intended for direct dispensing to patients in the pharmacy where the preparation took place or in a pharmacy authorized to take them from this pharmacy pursuant to Section 79 (9) or intended for direct dispensing a veterinarian or animal keeper, or intended for direct use by the health service provider for whom the preparation has taken place,

(b) medicinal products intended for research and development purposes;

(c) intermediates intended for further processing by the manufacturer of medicinal products;

1. d) radionuclides in the form of sealed emitters,

(e) whole blood, plasma or blood cells of human origin and transfusion products, with the exception of plasma produced by a method involving an industrial process;

(f) medicated feedingstuffs;

(g) veterinary autogenous vaccines;

1. h) radiopharmaceuticals prepared in accordance with the instructions of the marketing authorization holder exclusively from registered radionuclide generators, kits or radionuclide precursors for immediate use in the nuclear medicine workplaces of health service providers authorized to perform activities under a special legal regulation13),

(i) advanced therapy medicinal products authorized under the hospital exemption.

For more information on registration of medicinal products, please visit sukl.cz or contact our law firm rutland & partners and we will be more than happy to help you with whole procedure.

For more information please contact:

Monika Rutland, partner

rutland & partners, advokátní kancelář s.r.o.

tel: +420 226 226 026

email: monika.rutland@rutlands.cz