ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of June 6, 2012 No. 422

About some questions of prohibition of advertizing of medicines

On accomplishment of the subitem 6 of Item 2 and item 4 of the Section I of the Law of Ukraine of December 20, 2011 No. 4196-VI "About introduction of amendments to some laws of Ukraine in health sector concerning strengthening of control of drug circulation, foodstuff for special dietary consumption, functional foodstuff and dietary additives" and for the purpose of strengthening of control of drug circulation of PRIKAZYVAYU:

1. Approve the Criteria applied in case of determination of medicines which advertizing is forbidden which are applied.

2. To the state company "State Expert Centre of the Ministry of Health of Ukraine":

2.1. Observe the Criteria approved by this order when conducting examination of registration materials on medicines which move on state registration (re-registration).

2.2. After decision making about reference of medicine to medicines which advertizing is forbidden to provide entering of the relevant information into the State register of medicines of Ukraine.

3. To provide to management of development of the pharmaceutical sector of industry of health care in accordance with the established procedure state registration of this order in the Ministry of Justice of Ukraine.

4. To impose control over the implementation of the order on the deputy minister - the chief of staff of Bogachyov R. M.

5. The order becomes effective from the date of its official publication.

Approved by the Order of the Ministry of Health of Ukraine of June 6, 2012 No. 422

The criteria applied in case of determination of medicines which advertizing is forbidden

In case of state registration (re-registration) or modification of registration materials of medicine the decision on reference of medicine to medicines which advertizing is forbidden or about change of the status concerning advertizing owing to approval of changes in registration materials regarding addition or withdrawal of indications in the instruction for medical application with entering of the relevant information into the State register of medicines of Ukraine is accepted by the Ministry of Health based on recommendations of the state company "State Expert Centre of the Ministry of Health of Ukraine" in the presence of at least one of the following conditions:

1. Leave of medicine is performed only according to the recipe of the doctor.

2. Medicine contains drugs, psychotropic substances and precursors.

3. Trade name (including trademark or the name of the applicant (producer) in the presence) medicine same, as well as the medicine released according to the recipe vracha*.

4. Use of medicine can cause accustoming syndrome that is specified in the instruction for medical application, except medicines for external (local) application.

5. Medicine is applied only for treatment of women during pregnancy and feeding by breast.

6. Medicine is applied only for treatment of children up to 12 years.

7. Medicine, to approved, specified in the instruction for medical application to which indications treatment is referred:

venereal diseases;

especially dangerous infectious diseases;

cancer and other tumoral diseases;

chronic sleeplessness;

diabetes;

obesity (including the drugs used for reduction of body weight);

impotences (erectile dysfunction).

8. Medicine concerns to group of anatomo-therapeutic-chemical classification (ATH) on the J05A "antiviral medicines of direct action" code.

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* in case of use of this criterion it is necessary to consider that trade name of medicinal means name under which medicine is registered and which gives the chance to identify it. The trade name of medicine can be:

the fictional name which shall not lead to confusion with the commonly accepted name;

the commonly accepted name accompanied with trademark or the name of the applicant (producer);

the scientific name accompanied with trademark or the name of the applicant (producer).

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