Source: https://www.global-regulation.com/translation/denmark/613525/notice-on-advertising%252c-etc.-for-medicinal-products.html
Timestamp: 2020-01-24 21:03:20
Document Index: 405719837

Matched Legal Cases: ['§ 71', '§ 66', '§ 39', '§ 2', '§ 72', '§ 7', '§ 4', '§ 5', '§ 6', '§ 7', '§ 5', '§ 8', '§ 5', '§ 9', '§ 10', '§ 1', '§ 12', '§ 13', '§ 58', '§ 15', '§ 4', '§ 10', '§ 20', '§ 16', '§ 10', '§ 17', '§ 18', '§ 19', '§ 20', '§ 21', '§ 25', '§ 26', '§ 22', '§ 23', '§ 24', '§ 25', '§ 27', '§ 39', '§ 11', '§ 21', '§ 71', '§ 71', '§ 34', '§ 32', '§ 36', '§ 3', '§ 6', '§ 13', '§ 14', '§ 16', '§ 24', '§ 25', '§ 39', '§ 35']

Machine Translation of "Notice On Advertising, Etc. For Medicinal Products" (Denmark)
Notice On Advertising, Etc. For Medicinal Products
Original Language Title: Bekendtgørelse om reklame mv. for lægemidler
Advertising to health professionals
Advertising of the homeopathic medicinal products
Comparative advertising, advertising, pharmaceutical consultants
Persons engaged in the sale of medicines outside pharmacies
Cost justified discounts to pharmacies and others.
Template for audit statement on pharmaceutical suppliers ' performance of cost justified discounts
The full text of the ordonnance on advertising, etc. for lægemidler1)
Under section 67, paragraph 3, article 68, paragraph 1, article 70, paragraph 1, § 71 b, paragraphs 3 and 5, and section 104 (3) of law No. 1180 of 12. December 2005 on medicinal products, as amended by Act No. 1557 by 20. December 2006 and law No. 1258 by 18. December 2012, as well as under section 3 b, paragraph 1, and section 72 (2) of the Ordinance to the law on pharmacy company, see. lovbekendtgørelse nr. 855 of 4. August 2008, fixed: Chapter 1 definitions and scope section 1. By advertising for medicinal products shall mean any type of information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products.
(2). By public means anyone who is not a physician, dentist, veterinarian, pharmacist, nurse, veterinary nurse, business consultant or student within one of these subjects, see. the Danish Medicines Act § 66 (2).
(3). By health-care professionals means doctors, dentists, veterinarians, pharmacists, nurses, veterinary nurses, midwives, laboratory staff, pharmaconomists, clinical dietitians, x-rays and students of these subjects.
(4). By suppliers shall mean holders of authorisation under medicines Act § 39, paragraph 1, for the manufacture, introduction or distribution of medicines.
(5). At the pharmacy-only drugs means drugs that may only be marketed to users through pharmacies, see. the Danish Medicines Act section 60, paragraph 1.
§ 2. Rules on advertising for medicinal products in Danish Medicines Act Chapter 7 and in this Ordinance shall not apply to: 1) medicines labelling and package leaflet.
2) Individual correspondence, if necessary accompanied by documents of non-commercial nature, which serves to answer a specific question about a particular medicinal product.
3) necessary and concrete information or documentation that serve safety and not promotional purposes.
4) price lists, product catalogs and the like, that does not contain other information about the medicines than names and prices. Publications must not contain information about competing drugs.
5) information materials on health and illness, provided that either directly or indirectly referred to specific drugs.
6) Patient information leaflets issued by the issuer in connection with prescription prescription of a medicine or pharmacy in connection with the dispensing of a drug, and that contains only objective information of importance to the patient and his relatives. The contents of the folder must not be in conflict with the summary of product characteristics.
7) press releases, a) that contain concise information about a drug, b) which has a general news value, c) that has the press as audience, and d) broadcast to or made available to a plurality of journalists or media for the purposes of journalistic assessment and processing before publication.
8) Unedited and unabridged version of authority approved information about a drug in the form of leaflet, summary of product characteristics or publicly available evaluation report referred to in article 6. the Danish Medicines Act § 72, paragraph 1, on condition that the information be made available in such a way that users must actively seek out information.
Chapter 2 general prohibition section 3. There must not be advertised 1) drugs, which are not legally negotiable or dispensed in this country, without prejudice. section 64 of the Danish Medicines Act, no. 1, 2) extemporaneous medicaments, see. section 64 of the Danish Medicines Act, no. 2, 3) medicinal products for clinical and non-clinical trials, when not issued a marketing authorisation for the medicinal products referred to in article 6. the Danish Medicines Act § 7, 4) medicines, sold or dispensed pursuant to a compassionate after the Danish Medicines Act section 29, and 5) sera, vaccines, immunoglobulins and other specific immunological test preparations, which are not covered by a marketing authorisation, and which are sold or dispensed from the Danish State Serum Institute or Veterinary Institute at the Technical University of Denmark pursuant to section 30 of the Danish Medicines Act.
Chapter 3 advertising to the general public
§ 4. Advertising to the general public shall be designed so that it is clear that this is advertising, and that the advertisement deals with a drug.
§ 5. Advertising must, except in the cases referred to in section 6 and section 7 shall contain the following information: 1. name of the medicinal product and common name).
2) package sizes.
3) Dated pricing (register price) Inc. VAT and reference to the fair current price at medicinpriser.dk, if the medicine is Pharmacy reserved, without prejudice. the Danish Medicines Act section 60, paragraph 1.
4) effect. However, section 10, paragraph 1, no. 13.5) side effects.
6) dosage.
7) an explicit and legible invitation to read the information in the package leaflet or on the packaging.
8) such other information as is necessary for the purpose of the correct and appropriate use of the drug, such as warnings and interaction conditions.
(2). Indication of the effect of a traditional herbal medicinal product, must see. the Danish Medicines Act section 34, no. 2, be formulated thus: ' traditional herbal medicinal product for use in (indication (s) must be specified). The effect is only established through long experience with the use of the plant (or plants) ".
(3). If a veterinary drug is approved for use in several animal species, and an advertisement solely will be applied against persons who have a specific interest in a single animal species, can the compulsory information shall be limited to information that is relevant to this particular species.
Advertising in the open air, on film and in radio
§ 6. Advertising in the open air, on film, including video footage, and on the radio must contain the following information: 1. name of the medicinal product and common name). If the medicinal product contains more than one active substance, the Board, however, is omitted.
2) effect.
3) Significant side effects.
4) An express invitation to read the information in the package leaflet or on the packaging.
5) An express invitation to contact the doctor (or vet) or pharmacist in case of doubt.
(2). Indication of the effect of a traditional herbal medicinal product must be carried out in accordance with article 5, paragraph 2.
§ 7. Advertising on television must contain the following information: 1) name of the medicinal product.
5) An express invitation to read more about the drug on that tv channel, teletext and on the Internet. The holder of the marketing authorisation for the medicinal product shall publish all the information specified in § 5, on teletext and the Internet.
6) page numbers on teletext and internet address where the in no. 5 the information referred to is published.
(2). In paragraph 1, no. 1-5, information mentioned must be noted in the easy-to-read text on the screen or most be read aloud.
(3). In paragraph 1, no. 6, said information must be entered into readable text on screen.
(4). The provisions of paragraph 1, nr. 1-4, shall also apply to the advertising that appears on monitors in pharmacies or other stores that sell drugs, assuming that there is free access to the Internet from a PC, information stands, etc. in the pharmacy or store room. The advertisement shall also contain: 1) An express invitation to read more about the drug on the Internet. The holder of the marketing authorisation for the medicinal product shall publish all the information referred to in section 5, on the Internet.
2) Internet address, where they in no. 1, the information is published.
3) indicating that there is free access to the Internet from a PC, information stands, etc. in the pharmacy or store room.
(5). All the information referred to in paragraph 4 must be specified in the text on the screen.
§ 8. In §§ 5-7 information referred to whom (or most be read aloud) so clearly, that the natural audience for the advertisement effortlessly can read (or hear and well to perceive) information.
§ 9. Advertising of medicinal products on the Internet are subject to the same rules as other advertising of medicinal products.
(2). Advertising on the Internet will be treated as advertising to the general public, see. However, paragraph 3.
(3). Advertising on the Internet, where access to information via demands for personal access code or by other effective means is limited to health professionals and persons involved in the sale of medicines outside pharmacies, are treated as advertising to health professionals and others.
§ 10. Advertising to the general public must not 1) give the impression that it is superfluous to consult a doctor or veterinarian, 2) give the impression that the effect of the drug is safe (guaranteed), is without side effects or are better than or as good as the effect of a different treatment, including another drug, 3) give the impression that the general well-being can be improved by the use of the medicinal product , 4) give the impression that the general well-being may be affected if the medicinal product is not in use, 5) solely or mainly apply to children, 6) contain a recommendation from health professionals, researchers or other individuals, groups of individuals, institutions, companies, etc. which, by virtue of their reputation, etc. can encourage the consumption of medicinal products, 7) equate medicine with foodstuffs, cosmetic or other consumer goods, 8) give the impression of that the safety of the medicinal product or efficacy is due to the fact that the ingredients come from nature, 9) be fit to lead to erroneous self diagnosis, 10) contain exaggerated, frightening or misleading claims of recovery, 11) at excessive, frightening or misleading way make use of pictorial representations of changes in the human body caused by disease or injury, or of the impact of a medicinal product on the human body or parts thereof; , 12) include a statement that the medicinal product is authorised by the competent authority, 13) directly or indirectly mention serious diseases or symptoms of serious diseases or 14) contain references to studies, literary works, periodicals, etc.
(2). The provision in paragraph 1, no. 4, shall not apply to vaccination campaigns, which are approved by the Danish Medicines Agency, see. section 66 of the Danish Medicines Act, paragraph 4.
Chapter 4 advertising to health professionals section 11. Advertising of a medicinal product in the face of health-care professionals must contain the following information: 1. name of the medicinal product and common name). The common name must be specified with the same types and on equally prominent way as the drug's brand name. For combination products without a common name should be given clear information on the common names of all the active ingredients.
2) the name of the holder of the marketing authorisation.
3) indications, as stated in the summary of product characteristics. In advertising, which solely caters to a specific group of health professionals, the indication of the therapeutic indications is restricted to what is relevant to that group.
4) contraindications.
5) side effects and risks.
7) pharmaceutical forms.
8) sizes.
9) Dated pricing (register price) Inc. VAT and reference to the fair current price at medicinpriser.dk, if the medicine is Pharmacy reserved, without prejudice. However, paragraph 4.
10) dispensing group.
11) reimbursement status.
(2). If a drug is approved in several pharmaceutical forms with different scopes, and the advertisement exclusively deals with one of the pharmaceutical forms, the advertisement shall contain only information on this pharmaceutical form. Furthermore, it should be stated in the advertisement that the medicinal product is also found in other dosage forms.
(3). If a veterinary drug is approved for use in several animal species, and the advertisement exclusively deals with the treatment of a single species, the advertisement shall contain only information about the treatment of this species. Furthermore, it should be stated in the advertisement, that the drug is also approved for the treatment of other animal species.
(4). The price may be omitted in commercials that will be broadcast over 1) a longer period, if the advertisement is instead attached a price list, etc., or 2) is only targeted to in § 1, paragraph 3, referred to students.
(5). The information referred to in paragraph 1 must be so clear that the natural audience for the advertisement effortlessly can read them.
§ 12. Advertising that exclusively caters to health professionals, may be limited to the name of the medicinal product and common name.
§ 13. Information material about a drug, as in promotional purposes will be sent or handed over to health-care professionals, must include at least the in section 11, paragraph 1, the information referred to in annex IX. However, section 11 (2) and (3), and the date the material was drawn up or last revised.
(2). All information in the information material referred to in paragraph 1 shall be accurate, up-to-date, verifiable and sufficiently detailed for that recipient can form a personal opinion about the drug's therapeutic value.
(3). Quotations, tables, and illustrations from medical journals, scientific works, etc., used in the information referred to in paragraph 1, the material must be reproduced faithfully, and the exact source must be provided.
(4). As documentation for information on a medicinal product must, in addition to the summary of product characteristics, are used only scientifically sound studies. The studies must have been published in reputable and independent Danish or foreign stations, trade journals, etc. the studies prior to publication must have been subject to an independent evaluation.
Chapter 5 Advertising for homeopathic medicines section 14. Advertising of a homeopathic medicinal product which has been registered by a specific simplified procedure without documentation for the therapeutic effect. the Danish Medicines Act section 34, no. 3, and the Executive order on homeopathic medicinal products, etc., shall contain the following information: 1) The homeopathic strain or the scientific name of the strains according to homeopathic stocks followed by the degree of dilution.
2) Content quantity.
3) method and possible dosage.
4) name and address of the registration holder.
5) any important warnings.
6) the sentence: ' homeopathic medicinal product without approved therapeutic indications ', when the medicine is for human use, and the phrase: ' homeopathic medicinal product without approved therapeutic indications ', the animals when the medicinal product is intended for use in animals.
(2). Advertising of a homeopathic medicinal product to animals shall bear, in addition to the information specified in paragraph 1 shall contain information on the type or species of animal (s) the medicinal product is intended for.
(3). In addition, the advertisement must contain this information: 1) any medicinal product brand name (trade name), see. the Danish Medicines Act § 58.
2) pharmaceutical form.
3) composition.
4) manufactures, if this is different from the registration holder.
(4). By advertising on television may be the information referred to in paragraph 1, no. 2-4, is omitted, if they instead published on that particular television channel's Teletext and registration holder's internet address. The advertisement must contain an express invitation to read these for more information. Page numbers on teletext and internet address must appear clearly written on the screen.
(5). By advertising that appears on monitors in pharmacies or other stores that sell homeopathic medicinal products, the information referred to in paragraph 1, no. 2-4, be omitted if they are published on the registration holder's website, and there is free access to the Internet from a PC, information stands, etc. in the pharmacy or store room. The advertisement must contain an express invitation to read more about the drug on the registration holder's website. Internet address must appear clearly written on the screen.
(6). The advertisement shall not contain information other than what is stated in paragraphs 1-5.
§ 15. For homeopathic medicines within the scope of section 14 shall also apply to the provisions of § 4, § 10 and § § 20-30.
Chapter 6 comparative advertising, advertising, pharmaceutical consultants comparative advertising
§ 16. If an advertisement contains a comparison between several medicinal products, including a price comparison, it must clearly appear, which medicines, including what strengths, package size, and more, the comparison includes. The comparison must be limited to medicinal products, including strengths and package sizes, as it is objectively appropriate to compare, IE. medicines with coincident scope.
(2). Comparative advertising is to be drawn up on the basis of the information in the product characteristics of the medicinal products, which are included in the comparison.
(3). There may not be comparing medicines effect in advertising to the general public, see. § 10 (1) (8). 2. Storage of advertising material
§ 17. The advertising of a medicinal product shall retain a copy of the advertisement or other evidence of, see. the Danish Medicines Act, section 68, paragraphs 1 and 3.
(2). The advertisement must either be kept in printed form, etc. or digitally in a common format.
(3). In addition to the advertisement, this information must be stored: 1) The target group, i.e. the persons, as the advertisement has been applied to.
2) routing style.
3) a list of media in which the advertisement has been shown.
4) the time period during which the advertisement has been used.
§ 18. Medical sales representatives must have undergone an appropriate training in the company they work for, and be in possession of professional knowledge, there is adequate to ensure that they can provide accurate and complete information about the medicines they present or mention.
(2). Medical sales representatives shall, in respect of each medicinal product make product characteristics presented at the disposal of the person being visited. The summary of product characteristics should be supplemented with information about prices (if the medicine is Pharmacy-only) and reimbursement status.
§ 19. If a pharmaceutical consultant from persons he or she visits, get information on the application of one of the drugs that are presented, including about adverse reactions to the drug, pharmaceutical consultant must report this to the holder of the marketing authorisation for the medicinal product.
Chapter 7 economic benefits economic benefits for the public
§ 20. In connection with advertising, as well as technical information about medicines should not be given or offered to the public representation in the form of payment of expenses for meals, travel, accommodation etc.
Economic benefits for health professionals
§ 21. There must be no in advertising or otherwise to promote the sale of a drug is given or offered health-care professionals economic benefits referred to in article 6. However, paragraph 2, article 23, § 25, § 26, section 29 and section 30.
(2). The prohibition provided for in paragraph 1, does not include gifts of insignificant value, when the gift can be used in the recipient's business, or it is given to the recipient's anniversary, e.g. for an appointment or important birthday.
§ 22. There must be no in advertising or otherwise to promote the sale of a drug held competitions for and distributed prizes to health professionals.
§ 23. Notwithstanding the provision in article 21, paragraph 1, it shall be permitted to pay for services from a health care professional or pharmacist if remuneration proportionate to the service. As well as the recipient of the remuneration must provide for injunctive relief provide an indication of the basis for the determination of remuneration is at the disposal of the Danish Medicines Agency.
(2). The remuneration referred to in paragraph 1 may only be granted in the form of actual payment, not by offsetting, assignment of in-kind or other indirect way.
§ 24. Health-care professionals may not request or receive benefits, which is in contravention with article 21, paragraph 1, and section 22 and section 23.
Representation and sponsorship, etc.
§ 25. Notwithstanding the provision in section 21 (1), it is permissible to give or offer a health person 1) representation, in the form of payment of the direct costs of travel, accommodation, meals and the like, in connection with advertising and technical information on drugs and 2) professional information and education about drugs, in the form of payment of the direct expenses relating to courses, as well as other professional and scientific activities as health-care professionals participating in or organising.
(2). In paragraph 1, no. 1, said representation must be kept at a reasonable level and be strictly limited to the main purpose of the meeting, including be temporally subordinate to the promotional or professional activity. The representation must only include health-care professionals.
(3). By promotional or academic activity held abroad must be granted only payment to the benefits referred to in paragraph 1, if the holding abroad is justified on substantive, practical or economic circumstances. These essential circumstances must be documented in accordance with the injunction against the Danish Medicines Agency.
section 26. Notwithstanding the provision in article 21, paragraph 1, it shall be permitted to sponsor meetings with professional information on drugs that pharmacies are holding to the public.
(2). The sponsorship referred to in paragraph 1 may not exceed the direct cost of the Organization of the activity concerned, and representatives of the sponsoring undertaking shall not be involved in the organisation.
§ 27. There must not be paid for health persons participation in purely social or cultural events.
Chapter 8 persons engaged in the sale of medicines outside pharmacies section 28. For holders and employees at stores that are approved to sell non-pharmacy-only over-the-counter medicines or drugs for food animals, see. the Danish Medicines Act § 39, paragraph 1, and section 60 (2) and (3) the provisions of §§ 11-13, §§ 21-27, section 29 and section 30, if it is intended or the economic benefit relating to such drugs. However, these provisions apply only to employees who are employed with the mentioned drugs.
Chapter 9 Cost justified discounts to pharmacies and others.
Requirements for discounts
section 29. Notwithstanding the provision in article 21, paragraph 1, it shall be permitted to provide discounts on drugs, if the discount is based on cost cuts from the supplier, and is a direct result of a purchasing behaviour on the part of the recipient, which differs from the supplier's standard conditions (cost-justified discounts).
(2). The discount must be proportionate to the cost savings. A supplier must apply the same principles to calculate the discount for recipients, who exhibit the same purchase behavior.
(3). Shall not be eligible for discounts, as 1) is calculated on the basis of the supplier's purchase price or calculated with the vendor's purchase price as an element in the calculation, 2) is based on cost reductions resulting from rationalization internally at the supplier or 3) is based on discounts that are made by others to the supplier.
(4). Notwithstanding the provision of paragraph 3, nr. 3, the supplier may provide cost-justified discounts based on cost reductions in the form of discounts granted to the supplier of a service company, assisting the supplier with distribution of drugs (e.g. a carrier). The discount from the service activity must be based on a cost-relief with this as a result of the recipient's purchase behaviour, and discount must be proportionate to the cost relief.
Payment of discounts
section 30. Cost justified discount may only be granted in the form of a deduction from the retail vendor's purchase price. The discount must Access the direct purchaser of the product and could be related to delivery of the unique individual drugs or each batch of medicinal products.
Signage requirements for discounts on pharmacy-only medicines
section 31. Suppliers must draw up and publish updated information about access for pharmacists to achieve cost-justified discounts as part of trade in pharmacy-only medicines. The information must be clearly and readily available show published on the supplier's website on the Internet.
(2). The shell of the information referred to in paragraph 1 shall specify which delivery the supplier considers as standard and under what conditions, there are no discounts. Standard terms of delivery shall contain basic information about the related delivery conditions, including information on conditions concerning delivery frequency-quantum and time. It should also indicate what types of derogations in shopping behaviour in relation to the standard terms of delivery, the pharmacies must exhibit in order to qualify for discount.
(3). For information, see. paragraph 1, it shall also indicate which discount any given purchase behaviour, or the individual changes therein, maximum can trigger. Discount specified as a monetary amount or a percentage and can be measured within a range.
Documentation for discounts on pharmacy-only medicines
section 32. The documentation for granted cost-justified discounts on pharmacy-only medicines that suppliers pursuant to § 71 b of the Danish Medicines Act, paragraph 5, shall retain for 3 years, should include: 1) the information on access to obtain discounts that have been signposted with, including information about in which time period the discounts has been in force, as well as 2) invoices and credit memos issued not later than 30 days after shipment has occurred , with information about how the discounts have been composed and calculated.
section 33. The documentation for cost-justified received discounts on pharmacy-only drugs that pharmacists pursuant to § 71 b of the Danish Medicines Act, paragraph 5, shall retain for 3 years, must consist in invoices or credit notes issued not later than 30 days after shipment has occurred that contains the following information: 1) Drug name and number.
3) Received discount amount.
Management statement for discounts on pharmacy-only medicines
§ 34. Suppliers must, on the basis of the documentation stored pursuant to § 32 elaborate a management statement declaring, 1) to the stored evidence fulfils the conditions set out in section 32, to 2) that the discounts granted by the supplier in accordance with the elaborated and published information about access to achieve cost-justified discounts, see. section 31, as well as 3) that incidentally are granted discounts in accordance with the rules on cost-justified discounts in this order, including that they granted discounts commensurate with cost relief.
(2). Management declaration shall be drawn up for each calendar year and shall be submitted to the Danish Medicines Agency by 1. April of the following calendar year.
Review of discounts on pharmacy-only medicines
section 35. The documentation as suppliers shall keep under section 32 shall be subject to processing by a chartered or certified accountant.
(2). Auditor's treatment of the documentation should have included a review of: 1) about the discounts granted by the supplier in accordance with the elaborated and published information about access to achieve cost-justified discounts, see. section 31, as well as 2) about the discounts, incidentally, is provided in accordance with the rules on cost-justified discounts in this Ordinance, including those relating to the granted discounts commensurate with cost relief.
(3). Auditor to be based on his treatment in accordance with paragraphs 1 and 2 produce a statement of assurance. The statement of assurance shall be replaced according to the annex 1 showed template for audit statement on pharmaceutical suppliers ' performance of cost justified discounts. The statement of assurance shall be drawn up for each calendar year and shall be submitted to the Danish Medicines Agency by 1. April of the following calendar year.
§ 36. Cost justified discounts on all medicines, obtained by an Association of pharmacists (chemists chain), must immediately, directly and in full flow to each of the pharmacies that are part of the Association.
section 37. Associations of pharmacists may not request or receive discounts on pharmacy-only medicines that are not in accordance with the information on access to obtain discounts by the supplier pursuant to section 31 is obliged to compile and publish or which is otherwise in conflict with the rules of this order.
(2). Pharmacy chains must keep documentation (in the form of invoices or credit notes issued not later than 30 days after shipment has occurred) for achieved and transferred cost justified discounts on pharmacy-only medicines. Documentation must be retained for 3 years.
Chapter 10 Penalties and effective provisions of section 38. With fine punished anyone who violates § 3, nr. 3-5, section 4, section 5, paragraphs 1 and 2, §§ 6-8, section 10, paragraph 1, article 11, paragraphs 1 to 3 and 5, § 13, § 14, paragraphs 1, 2, 4 and 5, § 16, section 17 (2) and (3), sections 18-20, article 21, paragraph 1, article 22, article 23, paragraph 2, § 24, § 25, (2) and (3) section 26 (2), section 27 and sections 29-37.
§ 39. The notice shall enter into force on the 1. March 2013.
(2). Executive Order No. 272 of 21. March 2007 about advertising, etc. for medicinal products shall be repealed.
The Ministry of health and prevention, 27. February 2013 Astrid Krag/Nina Moss
Appendix 1 Template for laration pharmaceutical suppliers ' performance of cost justified discounts
Declaration of independent auditor
To The National Board Of Health
Upon agreement we have carried out the work actions, which are listed below relating to the pharmaceutical suppliers cost justified discounts, see. § 35 of Decree No. 272 of 21. March 2007 about advertising, etc. for medicinal products. Our statement has been prepared for the pharmaceutical supplier and health's use for the purpose referred to in this Declaration.
The goal of the agreed actions is that we work as auditors carrying out the audit similar labour actions regarding pharmaceutical supplier's cost justified discounts, as is required by the Ministry of Health and prevention audit instructions of 25. February 2008. We declare ourselves about the results of the audit performed similar work on the actions below, in the section "Actual results".
The following working operations are performed in accordance with the Danish auditing standard on agreed labour actions. Since the following working operations are not audit or review in accordance with Danish auditing standards thereof, pronounce ourselves alone on the actual results of the performed work acts and thus does not express a conclusion with certainty whether the pharmaceutical supplier alone has provided cost-justified discounts within the applicable rules to that effect.
If we had carried out further work actions, revised or completed the review in accordance with Danish auditing standards for doing so, could other conditions might be found and reported, and since the Declaration only concerns the conditions mentioned below, it cannot be extended to cover pharmaceutical supplier's accounts as a whole.
Our work is carried out in accordance with the Danish auditing standard on agreed labour actions.
Our actions can be summarised as follows: worked 1) we have a sample of x by the relevant annex [x, represent 10 per cent – but not less than 5 and not more than 25 paragraphs] controlled about pharmaceutical supplier shall keep evidence, in the form of invoices and credit memos, as well as the information on access to discount, as there has been sign with, concerning cost justified discounts, see. section 32 in the advertising order.
2) We have checked that the count of pharmaceutical supplier's cost justified discounts – as documented, see. section 32 in advertising the notice – match the discounts granted to pharmacists or pharmacy chains. We have a sample of x [x, represent 10 per cent – but not less than 5 and not more than 25 paragraphs] obtained confirmation from pharmacies and pharmacy chains on in calendar year received discounts.
3), we have a sample of x [x, represent 10 per cent – a minimum of 5 and maximum 25 paragraphs] controlled whether the discounts are in accordance with the supplier's drew up and published information about access to achieve cost-justified discounts. Control has been based on the cost of the pharmaceutical supplier retained documentation relating to reasoned discounts, including documentation in the form of the information about access to discount, as there has been sign with, as well as invoices and credit memos, see. Ad paragraph 32. Therefore not an audit examination includes inspection of the physical conditions that form the basis for the information referred to in the documentation stored on the granted discounts.
4), we have a sample of x [x, represent 10 per cent – a minimum of 5 and maximum 25 paragraphs] checks whether there is obviously the basis for believing that granted discounts, which is beyond the scope of the rules in sections 29-31 executive order on advertising and section 37, paragraph 1. Control has been based on the cost of the pharmaceutical supplier retained documentation relating to reasoned discounts, including documentation in the form of the information about access to discount, as there has been sign with, as well as invoices and credit memos, see. Ad paragraph 32. Therefore not an audit examination includes inspection of the physical conditions that form the basis for the information referred to in the documentation stored on the granted discounts.
We have found the following conditions: 1) example: No comments.
2) example: We found that the total pharmaceutical supplier's cost justified discounts – as documented, see. section 32 in advertising the notice – match the discounts granted to pharmacists or pharmacy chains. We have obtained confirmation from x pharmacies and pharmacy chains on the x in the calendar year received discounts.
3) example: we know the sample found that ...
4) example: No comments.
(Actual results must include sufficient details about found errors and exceptions).
(Chartered/Certified Accountant)
Official notes 1) Ordinance contains provisions implementing parts of a European Parliament and Council Directive 2001/83/EC of 6 May 2003. November 2001 establishing a Community code relating to medicinal products for human use, the official journal of the European Communities 2001, nr. L 311, p. 67.
1996 Medicines (Advertising) Regulations
1992 Council Directive 92/28/EEC of 31 March 1992 on the advertising of medicinal products for human use
2007 Royal Decree 1344 / 2007 Of 11 October, Which Regulates Pharmacovigilance Of Medicinal Products For Human Use.