Advertising Of Veterinary Medicinal Products Order

Original Language Title: Veterināro zāļu reklamēšanas kārtība

Read the untranslated law here: https://www.vestnesis.lv/ta/id/154196

Cabinet of Ministers Regulations No. 169 in Riga, March 6, 2007 (pr. 23. § 17) a veterinary medicinal product advertising order Issued in accordance with article 5 of the law of Pharmacy (5), article 56 of the law on Advertising and article 7 of the second part of rule 1 defines the order of the veterinary medicinal product and the order in which the veterinary medicinal product, the manufacturer is entitled to free samples of the veterinary medicinal product for practicing veterinarians and the veterinary education and science institutions.
2. These provisions shall not apply to: 2.1 veterinary medicinal products, labelling and instructions for use, which comply with the legislation on the labelling of the veterinary medicinal product, distribution, and control of these requirements.
2.2. informative notifications (such as packaging, warning of adverse reactions to veterinary medicinal products), trade catalogues and price lists, which have not been specified indications and the veterinary medicinal product does not contain advertising of medicinal products for veterinary use;
2.3. information that practicing veterinarian gives the owner of the animal for certain veterinary medicinal products required for a particular animal or group of animals;
2.4. the animal care advertising with no therapeutic effect on the animal;
2.5. animal healing feed advertising.
3. the advertising of veterinary medicinal products can be designed for: 3.1 the public;
3.2. veterinarians, who have the right to prescribe or distribute veterinary medicinal products (hereinafter referred to as the specialists).
4. it shall be prohibited to: 4.1 promote the veterinary medicinal product, which is not provided with a certificate of registration of veterinary medicinal products;
4.2. to promote veterinary medicinal products containing narcotic drugs or psychotropic substances;
4.3. to place advertising of veterinary medicinal products on prescription forms;
4.4. to advertise prescription of veterinary medicinal products intended for the public in advertising.
5. Advertising of prescription of veterinary medicinal products, the advertiser and ad distributor provides that the relevant information should be available only to professionals.
6. advertising of veterinary medicinal product shall meet the following requirements: 6.1 advertising provides information to comply with the instructions for use of the veterinary medicinal product in the information;
6.2. the information provided in the advertisement was objective, and it does not exaggerate the characteristics of the veterinary medicinal product;
6.3. the ad is not misleading;
6.4. the simplified registration process of homeopathic veterinary medicinal products registered in the ad may be used only in the labelling or the instructions for use included.
7. advertising in veterinary medicinal products for the public, allowed to advertise for veterinary medicinal products, their composition and the use is intended for use without a veterinarian's prescription and without the supervision of the official veterinarian. Advertising shall indicate the following: 7.1. name of the veterinary medicinal product, as well as the General name, if the veterinary medicinal product contains only one active substance;
7.2. call to carefully read the instructions for use of the veterinary medicinal product and the storage conditions or information on the packaging of the veterinary medicinal product;
7.3. the directions for the proper use of the veterinary medicinal product to animals.
8. advertising of veterinary medicinal products intended for the professionals, the following information (it is accurate, verifiable and sufficiently complete to be able to judge for the therapeutic effects of the veterinary medicinal product and the use of doses): 8.1. name of the veterinary medicinal product;
8.2. key information that matches the description of the medicinal product;
8.3. the nationality of the prescription of veterinary medicinal products or non-prescription drug group;
8.4. date when the ad was last matched in the State Agency of medicines.
9. The advertiser and ad distributor for veterinary medicinal products discharge or release not to be a professional offer, supply or promise any material or other types of values, and must not be such experts require.
10. Veterinary medicinal products free samples of the veterinary medicinal product manufacturers and distributors may be delivered only to specialists and veterinary education and science institutions, subject to the following conditions: 10.1. veterinary medicinal products free sample packaging meet the smallest trading unit;
10.2. free samples of the veterinary medicinal product is marked according to the legislation on the labelling of the veterinary medicinal product, and the label is a "free sample";
10.3. for every free sample shall be accompanied by a copy of the summary of product characteristics;
10.4. it is prohibited to distribute the narcotic drugs or psychotropic substances for veterinary medicinal products, free samples.
11. free sample of veterinary medicinal products, the manufacturer, the Distributor and recipient create and receive veterinary delivered free samples of the systems of accounting for and control of appropriate legislation on the labelling of the veterinary medicinal product, distribution, and control requirements.
12. a Person who distributes a prescription of veterinary medicinal products, free samples, each year until March 1 to submit a food and veterinary service of the report (in duplicate if the report is submitted in the form of a paper document) on all previous year common prescription of veterinary medicinal products, free samples. The report indicates the following: 12.1. name of the veterinary medicinal product;
12.2. the registration number of the veterinary medicinal product;
12.3. the package size;
12.4 prevalent free sample quantity (number of packages);
12.5. the person who delivered the veterinary medicinal products concerned, as well as free samples of the veterinary authority, in which the person works.
13. If a report is filed in paper form, one copy of the report remains in the food and veterinary service, and the other copy shall be marked "received" be returned to the person who submitted the report.
14. advertiser of the veterinary medicinal product under the competency provides: 14.1 State Agency of medicines and food and veterinary service approach: 14.1.1. preparing the advertising material samples, and information on the persons to whom the advertisement is addressed, as well as on the distribution of advertising and distribution start date;
14.1.2. details of person responsible for the advertising of medicinal products for veterinary use (first name, last name, phone number, and e-mail address);
14.2. the veterinary medicinal product, compliance with this provision of the advertising requirements;
14.3. the National Agency for medicines, pharmaceutical inspection and the State food and veterinary service to provide information and assistance necessary for the performance of their duties.
15. If the veterinary medicinal product is organized ad-related workshops, conferences, exhibitions or other events, the event organizer shall inform the appropriate expertise in the pharmaceutical and food inspection and veterinary services for the program of the event, location, and time.

16. promotional distribution of veterinary medicinal products authorised to launch after the State Agency of medicines has been evaluated by the advertiser or advertising vendor (hereinafter the applicant) submitted advertising material in compliance with these rules and advertising requirements set out in law. The applicant shall provide the State Agency of medicines: 16.1. advertisements veterinary medicinal product evaluation application. The application indicates the applicant (name or first and last name, address), the manufacturer of the veterinary medicinal product, the name of the medicinal product, in the form and strength of the veterinary medicinal product, the registration number, the person to whom the advertising of medicinal products for veterinary use intended for advertising, the language in which the ad is intended for distribution, promotion and evaluation of the person providing payment for the evaluation of advertising, as well as an indication of the desired type of receipt of the decision;
16.2. the veterinary medicinal product, the ad text in the Latvian language and all the languages in which the ad will be distributed in the territory of Latvia;
16.3. the promotional image of the veterinary medicinal product or, if the video is intended for other types of advertising (not just word-of-mouth);
16.4. the veterinary medicinal product advertising audio if the audio is provided for advertising;
16.5. all advertising proofs of the above facts, which are not listed on the registration of veterinary medicinal products.
17. the State Agency of medicines has the right to request additional information this provision referred to in paragraph 16 to fine-tune the document.
18. the State Agency of medicines shall within 15 working days or, if it is intended to speed up the evaluation of veterinary medicinal product advertising, five or 10 working days after the receipt of the required documents by the beneficiary of the decision issued by a specified decision of the veterinary medicinal product, advertising or refusal of consent of the veterinary medicinal product under the ad. The decision shall specify the grounds for refusal and opposition procedure. National Agency of medicinal products a copy of the decision electronically sent to the food and veterinary service.
19. the State Agency of medicines of the decision on the refusal to match the advertising of veterinary medicinal products adopted in the following cases: 19.1 advertising does not comply with these rules or the Act of identifying Thai Advertising requirements;
19.2. the evaluation of veterinary medicinal product advertising application is not filled in according to the requirements of this regulation;
19.3. the evaluation of veterinary medicinal product advertising is attached to the application for all 16 of these rules the texts referred to in the paragraph.
20. where necessary to assess the additional information, the State Agency of medicines has the right to a decision to extend the deadline until 30 days after notifying the applicant.
21. The applicant, in accordance with the State Agency of medicines of pricing public services paid for submitted advertising material and evaluation under playlists.
22. If a State Agency of medicines in the agreed advertising material changes are made, the applicant is responsible for their coordination in accordance with the procedure laid down in these provisions.
23. If the registration of veterinary medicinal products in an approved changes that conflict with the State Agency of medicines of the agreed advertising material for veterinary medicinal products, the applicant shall inform the appropriate competence, the State Agency of medicines and food and veterinary services and the stopping of the veterinary medicinal product advertising.
24. According to The rules of competence monitoring State Pharmacy Inspectorate and the food and veterinary service.
25. national pharmaceutical inspection and food and veterinary service launched under the competency check on possible violations of the veterinary medicinal product in advertisements or on its own initiative in the following cases: 25.1. an application or complaint is received about the regulations establish requirements for non Thai veterinary medicinal product advertising;
25.2. you have received relevant information of another authority.
26. Be declared unenforceable in Cabinet the July 12, 2005 Regulations No. 503 "advertising order of veterinary medicinal products" (Latvian journal, 2005, 111 no). 
Informative reference to European Union directives, the regulations include provisions resulting from: 1) of the European Parliament and of the Council of 6 November 2001 of Directive 2001/82/EC on the Community code relating to veterinary medicinal products;
2) of the European Parliament and of the Council of 31 March 2004, Directive 2004/28/EC amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products.
Prime Minister a. Halloween Minister of Agriculture m. Roze Editorial Note: rules shall enter into force on 10 March 2007.