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Cabinet of Ministers Regulations No. 332 Riga, 17 May 2005 (pr. Nr. 2) 30 advertising of medicinal products order Issued in accordance with article 5 of the law of Pharmacy 5. General questions 1. determine drug (excluding veterinary medicines) advertising.
2. These regulations apply to any type of communication and the measures, if its purpose is to promote the drug prescribing, delivery, sale or use, as well as on: 2.1. public advertising of medicinal products;
2.2. those persons advertising for medicinal products, which have the right to prescribe or distribute medicines (hereinafter specialist): 2.2.1. provision of information on medicinal products by the advertiser's authorised person shall have the right to advertise medicines (medical representative);
2.2.2. distribution of samples of a medicinal product;
2.2.3. the urge to write or distribute a particular product offering of any material or other forms of remuneration or promise, except if its fair value is insignificant;
2.2.4. the costs associated with the participation of professionals in the advertising or scientific events (travel and accommodation expenses paid).
3. These provisions shall not apply to: 3.1 drug labelling and instructions for use, which comply with the legislation on the labelling of medicinal products, if they are not used separately from the product they advertise;
3.2. correspondence if it is not promotional in nature, and it is necessary to answer a specific question about a particular medicinal product;
3.3. for informational announcements and reference material, such as going to ņojum change, warning of side effects as one of general use precautions and trade catalogues and price lists, which have not been specified indications of preparations and drug advertising material;
3.4. notifications to human health or diseases, provided that they are not even indirectly to medicinal products;
3.5. information that the pharmacist or doctor will provide individual patients on certain medications that they need.
4. it is prohibited to advertise medications, which are not included in the Republic of Latvia registered in the list of medicinal products (they do not have a valid registration certificate) or not registered according to the European Medicines Agency to the centralised registration procedure.
5. Prohibited the advertising of medicinal products where the product is offered as a gift or refund on any purchase of goods or services or which are offered for the purchase of medicines (including herbal acquisition related offers to buy other products, goods or services at a discount).
6. General requirements of the advertising of a medicinal product are the following: 6.1 the ad matches the information in the summary of the report;
6.2. the information provided in the advertisement is objective and not overused medicinal properties;
6.3. the ad is not misleading.
7. Placing the advertising of medicinal products to goods, the advertisement must not conceal the product information (labelling, warnings, operating instructions and other manufacturers or distributors of the information provided), on which the ad is placed.
8. A simplified registration procedure for homeopathic medicinal products registered in advertising can only be used in the labelling or the instructions for use contain information.
II. Society for advertising of medicinal products to the public is prohibited 9. advertise: 9.1 prescription medications;
9.2. the medicinal products containing psychotropic or narcotic substances or their analogs.
10. Allowed to advertise medications that their composition and usage are intended and designed for use without a prescription and without medical supervision.
11. in paragraph 9 of these regulations these prohibitions do not apply to vaccines, which after coordination with the State Agency of medicines of the medicines manufacturer advertises the vaccination campaign information.
12. Drug manufacturers for promotional purposes is prohibited to distribute medicine to the public.
13. advertising of medicinal products to the public shall be made without any doubt that the information disseminated is ad and advertise the product is medicine.
14. If the rules referred to in paragraph 9 of the medicines advertised on the internet, advertisers and ad distributor provides information to be available only to professionals.
15. The public advertising of medicinal products provided for shall specify at least the following information: the name of the medicinal product 15.1., as well as legislation on the labelling of medicinal products prescribed generic name if the medicinal product contains only one active substance;
15.2. information necessary for the correct use of the medicinal product;
15.3. a clear and legible invitation to read carefully the operating instructions or information on the packaging.
16. the prescribed medicinal products to the public in advertising allowed only specify the name of the medicinal product, where advertising intended as a reminder to the previously widespread advertising.
17. If, in accordance with the provisions of paragraph 11 of the advertised, advertising, in addition to the vaccine that rule 15 the information referred to in paragraph indicates the call to consult a doctor.
18. the prescribed medicinal products to the public is prohibited in advertising to include information that: 18.1. recommends treatment via postal services or providing advice on another similar way, and gives the impression that the diagnosis does not need a doctor's advice;
18.2. creating the impression that the effects of taking the medicine are guaranteed, the use of the medicinal product does not cause the side effects and the action of the medicinal product is equivalent to that of other treatment or other medications, or is the better for it;
18.3. gives the impression that the use of medications, the patient's general health improved significantly;
18.4. creating the impression that without the use of the medicinal product concerned, to the patient's health may deteriorate. This condition does not apply to the provisions referred to in paragraph 11 vaccine ad;
18.5. only or mainly to attract the attention of children;
18.6. refers to scientists, health professionals or persons recommendations, that popularity could encourage the consumption of medicinal products;
18.7. creating the impression that the medicinal product is a foodstuff, cosmetic or other consumer product;
12.8. gives the impression that the safety and effectiveness of medicines ensures natural origin;
11.7., by a description or detailed representation of a case history, could lead to erroneous pašdiagnoz;
18.10. inappropriate, satraucošo or confusing terms describes the recovery;
18.11. improper, alarming or misleading terms, pictorial representations of changes in the human body caused by disease or injury, or of the action of a medicinal product on the human body or parts thereof;
18.12. encouraged to purchase medicines, giving the medicine purchasing need with medicine prices.
III. Professional advertising of medicinal products for professionals in 19 drug advertising indicates at least the following: 19.1. key information that matches the description of the medicinal product;
19.2. the medicine affiliation or non-prescription medicines prescription groups;
19.3. the medicine current or expected retail price, as well as the conditions of refunds if the product in question is included in the list of medicinal products eligible;
19.4. the date when the ad was last matched in the State Agency of medicines.
20. Experts proposed in the advertising of medicines allowed to specify only the name of the medicinal product, where advertising intended as a reminder to the previously widespread advertising.
21. Experts proposed in the advertising of medicines information should be: precise, updated 21.1, verifiable and complete the recipient to be able to judge on the therapeutic value of the medicinal product concerned;
21.2. accurately quoted from medical journals or other scientific publications, with citations, table, and other literature sources.
22. Professionals advertising medicinal products only intended for professionals in the scientific press and in particular the voto sagat or promotional material that does not spread to the rest of the public.
23. The advertiser and ad Distributor on the discharge or release may not be delivered, offer or promise of any material or other types of remuneration, except where it is applied to the practice of medicine or pharmacy and its material value is not significant.
24. Activities with professional and scientific orientation representation expenses are strictly limited and are subordinate to the main purpose of the event and they must relate to the specialists.
25. Professionals should not ask, require or accept any material or other types of remuneration, except that the provisions referred to in paragraph 23 of the cases, where it is not contrary to the provisions of the conditions referred to in paragraph 24.
26. Free samples distributed medical representatives. Free samples shall be provided only in persons who have the right to prescribe drugs, subject to the following conditions: 26.1. free samples package may not be greater than the smallest trading unit of the medicinal product concerned;
26.2. free samples under the law on the labelling of the medicinal product requirements is marked with the indication "free sample";
26.3. for each free samples shall be accompanied by a copy of the summary of product characteristics;
16.4. If the medicinal product contains under the supervision of the Ministry of health of the existing psychotropic or narcotic substances may not be delivered to the free samples;
26.5. free samples shall be provided in accordance with the applicant's signed and dated written request;
16.5. free samples of supplier and recipient create free samples delivered to accounting and control system;
16.6. one doctor delivered no more than three one-name prescription free samples a year. Overall, during the year, all the doctors delivered no more than 500 one-name prescription free samples.
27. a Person who distributes a free prescription drug samples each year to 31 January the State Agency of medicines shall be submitted a report (in duplicate) of all previous year common prescription free samples. The report indicates the following: 27.1. name of the medicinal product;
27.2. registration number;
27.3. the package size;
27.4. common free sample quantity (number of packages);
27.5. persons who delivered the free samples, as well as the medical establishment, in which the person works.
28. One copy of the report remains the State Agency of medicines and the other copy shall be marked "received" be returned to the person who submitted the report.
IV. Requirements reklamējam registration certificate holder (owner), the manufacturer's authorised person and medical representatives 29. The holder of the registration certificate (the owner) under the competency provides: 18.1. to the Ministry of Health, State Agency of medicines and the national pharmaceutical inspection would be available on all of the promotional material and information about the persons to whom the advertisement is addressed, as well as on the distribution of advertising and distribution start date;
29.2. the advertising of medicinal products to meet these rules;
29.3. to his existing medical monitoring agents would be trained and carry out duties in accordance with these rules;
18.3. to the Ministry of Health, State Agency of medicines and the country's pharmaceutical authorities to provide information and assistance necessary for the performance of their duties.
30. the registration certificate holder (owner) creates the scientific service, providing information on medicinal products represented.
31. foreign pharmaceutical manufacturer's authorised representative not later than one month after the start of operations in Latvia submitted to the national agency of medicinal products and the pharmaceutical inspection in the country of the person responsible for placing the medicinal product on the market, giving the name of the person concerned, education, as well as business telephone and fax number.
32. The employer shall ensure the training of medical representatives, so they can provide accurate and complete information on reklamējam products.
33. The medicine specialist, medical representative also issued a summary of reklamējam.
34. The medical representative to this provision in paragraph 30 above, the scientific Department all the information about the use of medicinal products reklamējam, with particular reference to adverse reactions observed in accordance with the information provided by the experts.
V. supervision of the advertising of a medicinal product 35. distribution of the advertising of a medicinal product authorised for instituted 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: 21.8. evaluation of the application of the advertising of a medicinal product (annex);
35.2. text in Latvian advertising of medicinal products in the language and in all languages in which the ad will be distributed in the territory of Latvia;
35.3. the Visual image of the advertising of a medicinal product or, if the video is intended for other types of advertising (not just word-of-mouth);
35.4. audio advertising of medicinal products, if the sound is provided for advertising;
22.1. media advertising of medicinal products or the sample image, if, in accordance with the requirements of this regulation are intended only as a reminder;
35.6. receipt for all facts mentioned in the ad, which is not specified in the registration dossier.
36. before the State Agency of medicines shall be submitted in the application for comparative advertising of medicinal products, the applicant for the coordination of this ad shall inform the competitors whose interests could be affected.
37. To coordinate vaccination campaigns during the vaccine to be used in advertising, in addition to these provisions, the applicant 35. information referred to in paragraph 1 shall be submitted to the State Agency of medicines: 37.1. period during which the planned vaccination campaign;
37.2. the measures provided for in the vaccination campaign.
38. the State Agency of medicines has the right to request additional information 35. these provisions and documents referred to in paragraph 37 to fine-tune.
39. the State Agency of medicines shall within 15 working days or, if it is intended to speed up the evaluation of the advertising of a medicinal product, — 5 or 10 working days after receipt of all the required documents are issued a written decision concerning the reconciliation of the advertising of a medicinal product or the refusal to match the advertising of medicinal products. The decision shall specify the grounds therefor and for appeal.
40. the State Agency of medicines shall adopt the decision on the refusal to match the advertising of medicinal products in the following cases: 24.9. advertising does not comply with these rules or statutory requirements;
40.2. the evaluation of the application of the advertising of a medicinal product is not completed according to the requirements of this regulation;
40.3. the evaluation of the application of the advertising of a medicinal product is not accompanied by all the rules of the documents referred to in paragraph 35.
41. where necessary to assess the additional information, the State Agency of medicines has the right to a decision to extend the time limit to 30 days by notifying the applicant.
42. the National Agency for Medicines reconciliation on the advertising of medicinal products is valid for two years. The exception is the rule referred to in paragraph 11 vaccine ads that reconcile to the time of the vaccination campaign.
43. The applicant, in accordance with the State Agency of medicines of pricing public services paid for submitted advertising material and evaluation of the vaccination campaign.
44. If a State Agency of medicines in the agreed advertising material changes are made, the applicant is responsible for the harmonisation of these rules 35, 37, 38, 39, 40, 41, 42 and 43 in.
45. If the registration documentation approved changes that conflict with the State Agency of medicines of the coordinated advertising material for medicinal products, the applicant is responsible for the State Agency of medicines information and stop advertising of medicinal products.
46. where medicinal products are organised exhibitions, advertising of a medicinal product-related workshops, conferences, congresses, contests and other events, the event organizer, not later than seven days before the event concerned shall inform the national pharmaceutical inspection, submit the event program and specifying the event venue and time, event organisers and sponsors, participants, for advertising and other medicinal product-related information, as well as on the advertising of medicinal products by the person responsible.
47. Public organizations related to the field of pharmacy, can develop and after coordination with the Health Ministry to approve a uniform code of ethics of the advertising of a medicinal product that meets international ethical advertising of medicinal products.
48. in compliance with these rules is supervised by the national pharmaceutical inspection. Of the alleged infringements of the advertising of a medicinal product in the field of Pharmacy launched the national inspection testing, based on an application or complaint or on its own initiative.
VI. final question 49. Be declared unenforceable in the Cabinet of 30 January 2001, Regulation No 44 "advertising of medicinal products order (Latvian journal, 2001, nr. 19; 2003, 114 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, Directive 2001/83/EC on the Community code relating to medicinal products for human use;
2) of the European Parliament and of the Council of 31 March 2004 2004/27 of the directive amending Directive 2001/83/EC on the Community code relating to medicinal products for human use.
Prime Minister a. Halloween Health Minister g. Smith Editorial Note: rules shall enter into force on the 21 may, 2005.
Annex a Cabinet of 17 May 2005, regulations No 332 Health Minister g. Smith
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