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Clarifies 18.04.2007., Latvia journal Nr. 63 (3639) Cabinet of Ministers Regulations No. 167 in Riga, March 6, 2007 (pr. No 17 21) advertising of medicinal products and the order in which pharmaceutical company is entitled to doctors free samples of medicinal products Issued in accordance with article 5 of the law of Pharmacy (5) and article 56 of the law on Advertising and article 7 of the second part i. General questions 1. determines: 1.1. drug (excluding veterinary medicines) advertising;
1.2. the order in which the pharmaceutical company is entitled to doctors free samples of medicinal products. Medicines that are not marked as free samples, but which supplies free medical institutions (as gifts or donations), as well as samples of medicinal products free of charge medical institutions of education and Science (investigational drug) distributed in accordance with the laws and regulations on the distribution and quality control procedures.
2. the rules apply to any type of communication and the measures, if its purpose is to promote the drug prescribing, delivery, sale or use, including: 2.1 the 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 any other form of remuneration or promise, except if its fair value is insignificant;
2.2.4. with the participation of professionals in the advertising, or scientific activities related expenses (travel and accommodation expenses).
3. the rules do 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 changing packaging, warnings about side effects as one of general use precautions, as well as to the 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 specialist provides individual patients on certain medications that they need.
4. it is prohibited to advertise medications, which are not included in the Republic of Latvia in the list of medicinal products authorised or if they do not have a valid registration certificate, or they have not been 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 the purchase of a medicinal product-related offers to buy medicines, other 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. in accordance with the simplified registration procedure for homeopathic medicinal products registered in the ad may be used only in the labelling or the instructions for use included.
9. Advertising of medicinal products, which registered as a traditional herbal medicinal product, the advertisement shall contain an indication of the "traditional herbal medicine used in the following indications, based solely on the long-term results obtained".
II. Society for advertising of medicinal products to the public 10. it is prohibited to advertise: 10.1. prescription medicine;
10.2. the medicinal products containing psychotropic or narcotic substances or their analogues;
10.3. medicinal products acquisition costs borne in whole or in part from the State budget.
11. Allow the advertising of a medicinal product, their composition and usage are intended and designed for use without a prescription and without medical supervision.
12. This provision, the prohibition referred to in paragraph 10 shall not apply to vaccines, which after coordination with the State Agency of medicines of the medicines manufacturer advertises the vaccination campaign information.
13. Drug manufacturers for promotional purposes is prohibited to distribute medicine to the public.
14. 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.
15. If that rule 10 referred to medicines advertised on the internet, advertisers and ad distributor provides information to be available only to professionals.
16. Public advertising of medicinal products provided for shall specify at least the following information: the name of the medicinal product 16.1, as well as legislation on the labelling of medicinal products and pharmacovigilance requirements laid down for izvirzāmaj instructions generic name if the medicinal product contains only one active substance;
16.2. information necessary for the correct use of the medicinal product;
16.3. a clear and legible invitation to read carefully the operating instructions or information on the packaging;
16.4. the call to consult a doctor or pharmacist about the use of the product;
16.5. If, in accordance with paragraph 12 of this rule promotes vaccines, indicates not call to consult a doctor or pharmacist about the use of the product, but a call to consult a doctor.
17. advertising of medicinal products to the public in the proposed permitted only the name of the medicinal product, where advertising intended as previously distributed advertising collection.
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 of paragraph 12 of that 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 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 previously distributed advertising collection.
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 quotes, tables, 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 is the alternative, 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 forms of remuneration, which is prohibited under this provision or paragraph 23 of these rules is in conflict with 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 added to the label with the inscription set in legislation on the labelling of medicinal products and pharmacovigilance instruction izvirzāmaj;
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, in Latvia controlled 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. overall, during the year, all persons have the right to prescribe drugs, delivered no more than 1000 single name prescription free samples;
26.8. not allowed to distribute samples of medicinal products containing isotretinoin.
27. a Person who distributes a free prescription drug samples each year to 31 January, submit national pharmaceutical inspection report of all the previous year common prescription of maritime industries and services, free of charge. 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.
IV. Requirements reklamējam registration certificate holder (owner), the manufacturer's authorised person and medical representatives 28. The holder of the registration certificate (owner): 28.1. 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;
28.2. the advertising of medicinal products to meet these rules;
17.6. to its existing medical monitoring agents would be trained and carry out duties in accordance with these rules;
28.4. to the Ministry of Health, State Agency of medicines and the country's pharmaceutical authorities to provide information and assistance that is required, making the monitoring of advertising of medicinal products;
28.5. immediate and full compliance with the decisions that are adopted by the State Agency of medicines and the national pharmaceutical inspection in connection with the supervision of the advertising of a medicinal product.
29. the holder of the registration certificate (the owner) creates the scientific service, providing information on medicinal products represented.
30. The holder of the registration certificate of medical representatives provide training, so they can provide accurate and complete information on reklamējamaj products.
31. Advertising of medicinal products specialist, medical representative also issued a summary of reklamējam.
32. The medical representative to this provision described in paragraph 29, 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 33. 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: 33.1. evaluation of the application of the advertising of a medicinal product (annex);
33.2. 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;
33.3. the image of the advertising of a medicinal product or, if the video is designed for other types (not just verbally) advertising;
20.8. audio advertising of medicinal products, if the sound is provided for advertising;
20.8. media advertising of medicinal products, a sample image or list that contains the medicine advertising medium, if in accordance with the requirements of this regulation are intended only as a reminder;
20.9. receipt for all facts mentioned in the ad, which is not specified in the registration dossier.
34. the State Agency of medicines shall not be subject to medicinal product advertising material intended for medical professionals and is used in the classroom this provision, paragraph 47.
35. the coordination of comparative advertising of medicinal products, if the ad directly or indirectly indicate that drug, which is the owner of the registration of a third party, the State Agency of medicines shall within 15 working days after the rules referred to in paragraph 33 of document information on harmonisation drug submitted for advertising on its site on the internet, including: 21.8. ad submission date;
35.2. the advertised name of the medicinal product or the international name;
35.3. reference the name of the medicinal product or the active substance farmakoterapeitisk group;
35.4. the applicant;
22.1. date until which a third party can provide.
36. The rules referred to in paragraph 35 of the third person is entitled to apply to the State Agency of medicines with a request to allow to become familiar with the submitted advertising material included in the comparison, as well as two weeks to submit their views and arguments. Before the advertising of medicinal products by the national agency of harmonisation shall assess third parties submitted views and arguments.
37. To coordinate vaccination campaigns during the vaccine to be used in advertising, in addition to these provisions, the applicant referred to in paragraph 33 of the information 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 33 and 37 of these regulations, paragraph to fine-tune the document. If the State Agency of medicines has not submitted all the required documents, or if the applicant submitted incomplete information, the Agency requires from the applicant's missing documentation or information.
39. the National Agency for medicinal products month after evaluation of the application of the advertising of a medicinal product shall be issued to the applicant in writing of the receipt of the decision on 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 for refusal and for appeal.
40. the State Agency of medicines shall adopt the decision on the refusal to match the advertising of medicinal products, if it does not comply with the Act and these regulations of advertising requirements.
41. The applicant has the right to request that the State Agency of medicines of the advertising of medicinal products evaluated in the short term – five or ten working days after submission of the application. In this case, the State Agency of medicines of the time limit specified by the applicant shall assess the documents submitted and take a decision on the ads agreement or refusal to match the advertising of medicinal products, as well as the decision taken shall inform the applicant in writing.
42. If the submitted information, dissemination of advertising of medicinal products to harmonise its due short term assessment is not possible, the State Agency of medicines has the right to examine the information submitted that the period referred to in paragraph 39.
43. the National Agency for Medicines reconciliation on the advertising of medicinal products is valid for an indefinite period. The exception is the rule referred to in point 12 vaccine ads that reconcile to the time of the vaccination campaign.
44. 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.
45. If a State Agency of medicines in the agreed advertising material changes are made, the applicant is responsible for the coordination of such provisions 33, 37, 38, 39, 40 and 44 in.
46. If the registration documentation changes approved or published clinical research data that is inconsistent with the State Agency of medicines of the coordinated advertising material for medicinal products, the applicant shall immediately inform the State Agency of medicines on the advertising of medicinal products do not conform to new data and stop the ads.
47. 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.
48. Non-governmental organizations associated with the field of pharmacy, can develop and approve a uniform code of ethics of the advertising of a medicinal product that meets the advertising Act, these regulations and the international ethical advertising of medicinal products.
49. 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 50. Be declared unenforceable in the Cabinet of 17 May 2005, Regulation No 332 "advertising of medicinal products order (Latvian journal, 2005, nr. 80).
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;
3) of the European Parliament and of the Council of 31 March 2004, Directive 2004/24/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use.
Prime Minister a. Halloween Health Minister v. Veldr is the Editorial Note: rules shall enter into force on 10 March 2007.
Annex to the Cabinet of Ministers of 6 March 2007 No. 167 of the rules of the advertising of a medicinal product evaluation application Health Minister v. Veldr MC
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