Can shampoo and soap be cosidered as medicinal products in Ukraine?
Considering the matter whether soap, shampoo, shower gel and other items of personal hygiene are drugs, we need to define terms of these objects, first of all.
Lawmaker doesn’t provide definition for a hygiene items, he only calls objects which must be considered as these items. It is items of oral care, skin care, hair care, items for and after shaving, toilet soap, shampoo etc.
Liquid or combination one or a few API (active pharmaceutical ingredients) which are used for prevention, healing or diagnostic of human’s illnesses is considered to be medical but only if it has natural, synthetic or biotechnological origin. Contraceptives and items which can change state and functions of a human body are also considered to be these ones.
Seek the truth into the legislation
There is the Law of Ukraine “On drugs” dated the 4th of April 1996 no. 123. The Article 2 gives a full list of items which are related to drugs. The list doesn’t have a direct indication on a shampoo against dandruff or on a bactericidal soap as drugs. And attentive reader will ask about these items. Unfortunately, lawmaker decided to shuffle the truth and divided it into pieces, hiding them into “law acts”!
There is the Decree of the Cabinet of Ministers of Ukraine “On approving the procedure of the state registration (reissue) of drugs…” dated the 26th of May 2005 no. 376. Actually, this law act is a permission act which turns a hygiene item into a drug.
This document gives a right to define whether goods are medical or hygiene by a manufacturer.
Considering abovementioned matters, there is a question how entrepreneur or legal entity which deals with production, for example medical shampoo, has to understand whether he or she must register it or not.
The final decision on affiliation is adopted by the central execute body which is responsible for composing a policy in a sphere of control on quality and safety of medical goods.
It means that, at first, manufacturer decides matter on classification of his or her product by himself or herself, but resolution will be adopted by the state in the end. The reason for permission is different criteria (composition, whether it passes clinical examination, whether it complies with standards etc.)
Manufacturer should keep in mind
So hygienic items (shampoo, soap etc.) are divided into two types: medical ones and cosmetic ones. The Law allows sale of two groups of goods. It is two parallel productions and border is too thin between them. As a rule this border is defined by lawmaker and gives opportunity to differentiate these directions clearly.
A hygienic item which must be registered in the Ministry of Health of Ukraine has to be consisted of one or a few API or has to be restorative, corrective or changing of human body’s function in a way of conducting pharmacological, immunological or metabolic action.
Registration of a hygienic item is conducted through submitting an application form into the Ministry’s chapters which deal with certification of drugs. The procedure of it is conducted in a few stages and launches according to results of examination of registration materials for its quality, held by the State expert center according to the rules which are defined by legal acts.
Body care items and drugs are close but different according to their features. Lawmaker putted information in different legal acts and we collected, analyzed and make a clear conclusion which gives answer for a question when hygienic item must be registered.
At the moment, legislation of Ukraine on drugs is updated in order to integral processes of entering country into the European Unity. It means if a manufacturer has a lot of questions, which need to be explained, and there is no time for dealing with them, then calling on a specialist will solve the problem.