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RESOLUTION OF THE CABINET OF MINISTERS OF THE REPUBLIC OF UZBEKISTAN

of December 15, 2014 No. 341

About approval of the Regulations on approval procedure on advertizing of medicines for minors

(The last edition from 29-10-2018)

According to the laws of the Republic of Uzbekistan "About allowing procedures in the sphere of business activity" and "About advertizing", and also the Resolution of the Cabinet of Ministers of the Republic of Uzbekistan of August 15, 2013 "About measures for implementation of the Law of the Republic of Uzbekistan "About allowing procedures in the sphere of business activity" the Cabinet of Ministers decides No. 225:

1. Approve Regulations on approval procedure on advertizing of medicines for minors according to appendix.

2. In a month to provide to the Ministry of Health of the Republic of Uzbekistan together with the interested ministries and departments reduction of departmental regulatory legal acts in compliance with this resolution.

3. To impose control of execution of this resolution on the deputy prime minister of the Republic of Uzbekistan A. I. Ikramov.

Prime Minister of the Republic of Uzbekistan

Sh. Mirziyoev

Appendix

to the Resolution of the Cabinet of Ministers of the Republic of Uzbekistan of December 15, 2014 No. 341

Regulations on approval procedure on advertizing of medicines for minors

I. General provisions

1. This Provision according to the laws of the Republic of Uzbekistan On allowing procedures in the sphere of business activity "and" about advertizing" determines approval procedure on advertizing of medicines for minors.

2. Medicine for minors (further - medicine) is the medicine allowed for use for prevention, diagnostics and treatment of diseases, used including, according to the instruction on medical application, persons which did not reach 18 years.

3. Advertizing of medicines is performed only in the presence of the permission issued according to this Provision.

Advertizing only of the medicines provided without recipe is allowed.

4. Issue of permission to advertizing of medicines is performed according to the scheme according to appendix No. 1 to this Provision.

5. Permission to advertizing of medicines (further - permission) is issued by the Ministry of Health of the Republic of Uzbekistan (further - authorized body) in form according to appendix No. 2 to this Provision.

6. In authorized body the advertiser, the producer of advertizing or the distributor of advertizing, legal entities and physical persons can file petition for issue of permission to advertizing (further - the applicant).

7. Permission is issued on effective period of the registration certificate of the medicine assumed to advertizing in the Republic of Uzbekistan.

It is granted permission for each advertized medicine separately.

8. Receipt of new permission instead of acting is necessary in case of change of the text of advertizing.

II. Allowing requirements and conditions

9. Conditions and requirements, obligatory to observance, for issue of permission is the following:

a) advertizing shall:

contain complete (including international pharmacological) the name of medicine and the name of the producer, information on use or use of medicine, including the main indications to application, information on availability of certificates;

be followed by the warning of availability of contraindications to application and use of medicine, about need of acquaintance with the instruction for application or receipts of consultation of specialists. To this prevention at least 10 percent of all space intended for advertizing or at least 5 seconds of broadcasting time at the beginning or at the end of advertizing filmlet on television and also the message in sound format at the beginning or at the end of advertizing of medicine on radio shall be reserved;

conform to other requirements established by the legislation imposed to advertizing;

b) advertizing shall not:

represent medicine as unique, the most effective, the safest on lack of side effects;

mislead concerning structure, origin, novelty or patentovannost of medicine;

discredit goodwill of rival producers or their trademark (service mark), trade name, products or activities;

refer to recommendations of scientists, workers of health care, and also officials of state bodies or other persons who owing to own popularity can encourage use of medicines;

contain material about purpose only or mainly for children;

show the situation showing the use by minors of medicine;

claim that safety and efficiency of this medicine is caused by its natural origin;

allow incorrect comparisons with other medicines for the purpose of strengthening of advertizing effect;

make impressions of uselessness of medical consultations or surgeries;

contain approvals that effect of this medicine with guarantee;

inspire that health of the person can be worsened by medicine non-use;

c) medicine availability in the List of the medicines released without recipe, approved by the Ministry of Health of the Republic of Uzbekistan;

d) medicine shall be registered in the Republic of Uzbekistan and have the existing registration certificate.

III. Documents necessary for receipt of permission

10. For receipt of permission the applicant submits the following documents to authorized body:

a) the statement for issue of permission in form according to appendix No. 3 to this Provision;

b) No. 1001 is excluded according to the Resolution of the Cabinet of Ministers of the Republic of Uzbekistan of 20.12.2017

c) promotional materials (text, scenario, video, audio, Article, module, etc.);

d) the bank document about payment of collection for consideration of the application about issue of permission.

11. The requirement from the applicant of submission of documents, not stipulated in Item the 10th this provision, is not allowed.

12. The documents necessary for receipt of permission are represented by the applicant to authorized body directly, through means of mail service or electronically with the notification on their obtaining. The documents submitted electronically are confirmed by the digital signature of the applicant.

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