Order On Prescriptions

Original Language Title: Bekendtgørelse om recepter

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Overview (table of contents)

Chapter 1

Prescription and prescription


Chapter 2

Recep Foresters content and validity


Chapter 3

Electronic, telephone and fax prescriptions


Chapter 4

Foreign prescriptions


Chapter 5

Prescription Expedition


Chapter 6

Storage and transmission of prescriptions for narcotic drugs


Chapter 7

Medicine requisitions


Chapter 8

Delivery Groups


Chapter 9

Recall, dispensing without guarantee of payment and exemption


Chapter 10

Criminal and entry into force


The full text
Order on prescriptions
Pursuant to § 38 paragraph. 1, § 42 paragraph. 2-4 and § 72 paragraph. 2 of the Law on Pharmacies, see. Legislative Decree no. 855 of 4 August 2008, as amended by Act no. 465 of 18 May 2011, § 61 paragraph. 2-3 and § 62 paragraph. 1 of Law no. 1180 of 12 December 2005 on medicinal products, as amended by § 1 of the Law no. 1557 of 20 December 2006 amending the Law on medicines, the Law on Pharmacies Act, and the veterinarians determined:

Chapter 1

Ordination and prescription

§ 1. When a prescription means a regulation (prescription) from a doctor, dentist or veterinarian for the extradition of drugs from a pharmacy or a prescription from a veterinarian for dispensing by a holder of a license under § 39 paragraph. 1 of the Act on drugs for distribution to users of medicines for production.

PCS. 2. When a prescription is further understood a written prescription (order form) from a doctor, dentist or veterinarian for the extradition of medicinal gases from a pharmacy or a holder of a license for retail sale of medicinal gases, see. § 39 PCS. 1 of the Act on drugs. The requirements for presentation and storage and distribution conditions for such a prescription (order form) stated in the Order of medicinal gases.

PCS. 3. Ordination can be made in writing, electronically, by fax or by telephone.

PCS. 4. Doctors and dentists may as part of their business prescribe drugs for use for certain people, for use in practice or for their own use. Doctors authorized by Pharmacy Act § 8, may as part of their business also prescribe medicines for further disclosure. Veterinarians may as part of their business prescribe medicines for use in certain animals for use in practice or for further disclosure.

PCS. 5. A prescription can of prescribers used to notify the pharmacy that one of the doctor previously prescribed drug that dose dispensed, should be discontinued.

§ 2. In determining which drugs should be prescribed, particular emphasis is placed on whether the drugs

1) directly or indirectly constitute a health hazard, even when used correctly, if utilized without medical supervision,

2) directly or indirectly constitutes a health risk, because they frequently and extensively used incorrectly

3) contain substances or preparations whose efficacy or side effects it is necessary to monitor or

4) to be administered parenterally (injected or similar).

PCS. 2. Medicinal products for food-producing animals prescription, unless the following conditions are met:

1) administration of medicinal products is restricted to formulations requiring no particular knowledge or special skills

2) the drug does not involve a direct or indirect risk to animals treated, the person who gives the medicine or the environment, even if the drug is administered incorrectly,

3) the drug prescribing information contains warnings of potential serious side effects if used properly,

4) either the drug or other drugs with the same active substance has previously been the subject of frequent serious adverse reaction reporting,

5) SPC contains information about contraindications related to other veterinary medicinal product normally used without a prescription,

6) the medicinal product does not require special storage conditions,

7) residues in food obtained from treated animals do not pose a risk to consumer safety, even if the product is used incorrectly, and


8) there is no risk to human or animal health as regards the development of resistance to antimicrobials or anthelmintic, even if the medicinal products containing those substances are used incorrectly.

PCS. 3. According to the Medicine Pricing whether a drug prescription and whether it is subject to special watch described. § 4.

§ 3. Notwithstanding the provisions of § 2. 1 are the following drugs always prescription:

1) Extemporaneous drugs.

2) Medicinal products which have not been granted marketing authorization.

3) Drugs for animals to be authorized for marketing and containing a new drug whose use has been authorized for less than five years.

§ 4. In determining which medicines must undergo special watch described. § 15 and § 63, emphasis is given on whether the drugs

1) containing drugs, which are listed in Appendix B of Annex 1 to the Order on drugs in quantities that are not exempted from the provisions of that notice

2) by the unlawful use may be associated with risk of abuse and addiction, or

3) contain substances with new or special properties, which for safety reasons should be subject to special monitoring.

Chapter 2

Recep Foresters content and validity

Common rules for medical, dental and veterinary prescriptions

§ 5. A prescription must be written clearly and legibly. It should not contain abbreviations or characters that makes understanding doubtful or depending on the agreements between the prescriber and the pharmacist or the holder of the in § 1. 1, such authorization.

PCS. 2. A prescription should and should only contain the information required by this Order and any other information necessary for the processing of the prescription at the pharmacy or of the holder of the in § 1. 1, such authorization.

PCS. 3. A prescription must not consist of multiple sheets. This does not phone prescriptions.

§ 6. A prescription must contain

1) the date of issuance,

2) prescription issuer's handwritten signature and

3) printing or stamping information on the prescriber's name, position, address and telephone number.

PCS. 2. A prescription of drugs for personal use must contain the statement: "To his own use '.

PCS. 3. A prescription of drugs for use in prescription issuer practices shall include the words: 'For use in practice. "

§ 7. A prescription for a medicinal product for which the marketing authorization shall include the drug name, dosage form, strength (if the product is available in several strengths) and quantity. Strength and quantity must be stated clearly and in a way that changes can not be made. Prescriber can by emphasizing quantity indicate that this may not be as laid down. § 31

PCS. 2. A prescription for a drug to be dose dispensed, shall include in § 7, paragraph. 1, point 1. This information and endorsement "dose dispensing". The amount can be specified as a time period of no more than two years, which should be continuously dose dispensed. Have prescriber listed 'copy is desired, "the pharmacy must submit a copy of the prescription map to the prescriber.

PCS. 3. Should the extradition of a drug being dispensed dose, termination must contain the prescription in § 7, paragraph. 2, first sentence. information listed and labeled 'withdrawn'. Unless otherwise stated on the prescription, effected discontinuation with effect from the next delivery.

PCS. 4. A prescription for a magistral medicine must specify the medicinal composition, any manufacturing regulations and quantity. The amount must be stated clearly and in a way that changes can not be made.

§ 8. A prescription should include information on the indication, dosage and any relevant usage mode. The dosage indicated by per. time and the number of times per day. unit of time (day, day, day of the week, month, etc.). The instructions on the prescription must be easily understood.

PCS. 2. Ordained a drug in a non usual dose, the dose should be underlined or indicated by letters and numbers. Prescribing a drug to a non-conventional use, the use is stressed.

PCS. 3. prescriber can hand over a written dosing instructions instead of indicating the dosage on the prescription. On the prescription given in that case: "Dosing according to written prescription '.

PCS. 4. Paragraph. 1 does not apply to prescriptions for personal use, for use in practice or for further disclosure and for prescriptions after dispensing of a drug dose is dispensed, shall be terminated.


§ 9. any information about how many times and the intervals at which a drug may be handed over, must immediately below the prescription information relates. The information must be easily understood.

§ 10. A prescription is valid for 2 years after issuance. Prescriber may, by endorsement on a prescription indicate that its validity must be stopped at an earlier stage.

Medical and dental prescriptions

§ 11. Medical and dental prescriptions must be written on the prescription forms designed by the regions payroll and tariff boards in cooperation with the Danish Medicines Agency, unless exceptional circumstances prevent this, see. However, § 15 paragraph. 1.

PCS. 2. The §§ 6-9 and §§ 12-15 above information must appear directly on the prescription form. Prescriber may not involve the prescription form labels el

§ 12. A medical or dental prescription must contain the following information if the prescriber is in possession of the name or the number:

1) For doctors: Specialist designation and the identification code or hospital code.

2) For dentists: Outer Number.

3) For both doctors and dentists: Authorization ID.

§ 13. All electronically issued / printed medical and dental prescriptions shall bear encode indication and dosage to the extent that they appear in the electronic version of Medicine Prices.

§ 14. A prescription must indicate the name, address and CPR number. of the person, the drug is prescribed to or withdrawn. If the person's Social Security number. exceptionally, can not be obtained, shall be: 'Can not be obtained. " If the person has not been assigned a civil registration number. states: 'Not Assigned'.

PCS. 2. If a child under 16 has not yet been provided with a health insurance certificate must bear one of the parents CPR number. and the child's date of birth, whether the child has been awarded the CPR number.

PCS. 3. If a drug that is not equipped with warning that it may impair the ability to drive or operate hazardous machinery, cf. Order on labeling etc. of drugs shall bear the warning symbol, this shall immediately below the ordination.

§ 15. A doctor or dentist should be used when prescribing a drug that under § 4 shall be subject to special supervision, state or give her CPR number. Unless the prescription is done by an electronic prescription. If the prescription is not done by an electronic prescription and prescribing doctor or dentist does not want to give her CPR no., The prescription is written on a special Board of Health designed prescription form.

PCS. 2. Quantity and strength must be specified and figures letters referred to. However, § 20 paragraph. 3.

PCS. 3. There may be indicated only one prescription on each prescription.

PCS. 4. When prescribing methadone to patients in long-term treatment may be the number of times the drug can be provided expanded. There must not exceed prescribed for 1 month. Prescription must receives telephone or transmitted as an electronic prescription. In addition to the requirements that otherwise apply to telephone or electronic prescriptions must recipes include doctor's contact telephone number.

Veterinarian Prescriptions

§ 16. A veterinary prescription shall contain the following information in accordance. However paragraph. 2:

1) Vet authorization number.

2) its owner's name and address.

3) Species.

4) Code of species, age and ordination group, cf. Order on the submission of information to drug statistics.

PCS. 2. When prescribing drugs for use in veterinarian practice, the prescription include the following information:

1) Vet authorization number.

2) Practice Number.

§ 17. If a pharmacy-only medicine to be used for the treatment of animals kept for commercial purposes, the prescription is applied: 'Enterprise'.

PCS. 2. If a drug included in Medicine Prices under dispensing group "premix", "APK" or "BPK" shall be used for treatment of production, the recipe is applied: "For production animals".

PCS. 3. If a drug is for the treatment of animals in animal husbandry with CHR-number, the recipe, the CHR number.

PCS. 4. If a drug is for the treatment of animals whose meat or products used for human consumption shall be the recipe include waiting periods if there is

1) a veterinary medicinal product authorized in another species, or used in a non-approved dosage

2) a drug that is approved for human use, or

3) a magistral drug.


§ 18. handled prescriptions for drugs for animals or a copy of the recipes to be stored in the pharmacy or of the holder of the in § 1. 1 authorization referred to in 5 years.

PCS. 2. Can a prescription handled several times, must take a copy of the recipe for each expedition.

Chapter 3

Electronic, telephone and fax prescriptions

§ 19. Electronic, telephone and fax prescriptions must, with the deviations contained in this chapter shall be replaced as prescribed in Chapter 2.

PCS. 2. Veterinarians must not use electronic prescriptions.

PCS. 3. Ordination of extemporaneous drugs should not be made by electronic prescription.

§ 20. Electronic prescriptions kept for two years on the recipe server in the Agency Personal Electronic Medicine Profiles.

PCS. 2. Prescription Issuer's handwritten signature can be dropped on electronic prescriptions.

PCS. 3. Indication of volume and strength with letters can be dropped on electronic prescriptions, see. § 15 paragraph. 2.

PCS. 4. prescribing physician or dentist may cancel an electronic prescription that is not fully redeemed a prescription server in the Agency Personal Electronic Medicine Profiles.

PCS. 5. It must appear from an electronic prescription, which computer system prescriber uses.

PCS. 6. Systems for the transmission of electronic prescriptions shall be arranged so that the prescriber can be sure that prescriptions are transferred unchanged to the recipe server in the Agency Personal Electronic Medicine Profiles.

§ 21. The patient may require to obtain a list of prescriptions that are not delivered. If receptudsteders CPR number. seen from recipe, this information is not reflected in the overview.

§ 22. A telefax prescription may be transferred to the pharmacy or to the holder of the in § 1. 1, such authorization from the prescriber, see. However, § 24

PCS. 2. A facsimile prescription should of prescriber clearly marked: "Telefax Recipe '.

PCS. 3. A facsimile prescription from a doctor or dentist must be written in the in § 11, the prescription form.

§ 23. Indtelefonering of prescriptions may only be performed by doctors, dentists and veterinarians personally.

PCS. 2. prescriber must know indtelefonering provide all the information required for written prescriptions.

PCS. 3. Indtelefonering of prescriptions should only occur when special circumstances warrant it.

PCS. 4. A copy of telephone prescriptions for medicines for humans must be kept at the pharmacy for 3 months.

PCS. 5. A copy of telephone prescriptions for drugs for animals shall be stored in the pharmacy or of the holder of the in § 1. 1 authorization referred to in 5 years.

§ 24. A facsimile or telephone prescription may in special cases, for imperative reasons of patient requires, it is transferred from one pharmacy to another.

PCS. 2. The pharmacy that transfer a prescription to another pharmacist must document the course of action and the reasons for the transfer. The pharmacy receives the prescription, must exercise particular care when handling of the prescription.

PCS. 3. An electronic prescription that is not processed, can be traced back to the recipe server in the Agency Personal Electronic Medicine Profiles.

Chapter 4

Foreign prescriptions

§ 25. Prescriptions issued by doctors, dentists or veterinarians who are licensed in an EU country, and without obtaining authorization in Denmark during a temporary stay in this country carries medical, dental or veterinary activities, subject to the provisions of this Order.

PCS. 2. Prescriptions issued by doctors or dentists who are licensed in an EU country, Norway or Iceland, subject to the provisions of this Order. In addition, the following provisions apply:

1) Prescriptions of the in § 4, the drugs should not be executed.

2) The recipes must be issued in the prescribing physician or dentist's homeland.

3) The recipes may not be transferred electronically receives telephone or by fax.

4) Prescriptions of approved drugs, it will for Denmark say prescriptions for drugs for which a marketing authorization may only be executed if the product is marketed in Denmark and in the prescribing physician's homeland with the same quantitative content of active ingredient.

Chapter 5

Prescription Expedition

§ 26. The pharmacy and the holder of the in § 1. 1, such authorization may only dispense prescription drugs once a valid prescription.

PCS. 2. The pharmacy may dispense a prescription drug that is synonymous with the prescription if


1) the pharmacy does not have the prescribed product in stock and

2) the patient is likely to suffer serious medical damage if it synonymous product is not delivered, and patient care be postponed.

§ 27. The pharmacist and proprietor of the in § 1. 1, such authorization shall organize working procedures and routines at the pharmacy and the license holder's business locations in such a way that there is proper control and assurance

1) that the prescriptions processed, reads the provisions of Part 2-4,

2) the indication of the strength, dosage and application is deemed to be correct and that any interaction issues, and

3) the prescription is processed and drugs are labeled according to recipe's instructions and the requirements of this Order, and

4) the customer as necessary coached on medicinal use, etc.

PCS. 2. The pharmacist and proprietor of the in § 1. 1, such authorization shall prepare a script that describes workflows competence conditions, etc. for the reception and handling of prescriptions and dispensing of prescription drugs.

PCS. 3. The pharmacist and proprietor of the in § 1. 1, such authorization shall ensure that procedures and routines enables it at least 3 months after the expedition of a prescription can be cleared up who has contributed in the first paragraph. 1 pt. 1, 2 and 3, said control.

PCS. 4. The pharmacist and proprietor of the in § 1. 1, such authorization shall ensure that the personnel performing the prescription expedition following paragraph. 1 and 3, cf. Order on pharmacies and pharmacy staff and the executive order on distribution of medicines for production outside the pharmacy, through basic training and continued training to perform the job properly.

§ 28. If a prescription is not written in accordance with the provisions of Chapter 2-4, except § 12, no. 3, the pharmacist and proprietor of the in § 1. 1 authorization referred seek this rectified.

PCS. 2. If it is not possible to have any defects remedied or doubts clarified, the pharmacist and proprietor of the in § 1. 1, this authorization is not expedite the prescription, unless there is no reasonable doubt about the content prescriber wanted to give the prescription. The pharmacy must also expedite prescription if the patient is likely to suffer serious medical injury if the product is not delivered, and patient care be postponed.

PCS. 3. The pharmacy and the holder of the in § 1. 1, such authorization must document the company after paragraph. 1 and 2. The documentation shall be kept for 2 years, but in five years by supplying medicinal products to animals, see. § 18 paragraph. 1 pharmacist. The holder of the in § 1. 1, such authorization should be at the business address (main address) retain the record for 5 years, see. § 18 paragraph. 1.

§ 29. The pharmacy must inform the prescriber or, in the absence of a prescription, the patient's doctor if the pharmacy

1) provide another drug than prescribed, cf.. § 26 paragraph. 2

2) processes a prescription in cases where it has not been possible to get defects remedied or doubts clarified see. § 28 para. 2 or

3) on other grounds in exceptional cases where it is necessary for the patient's health, provide a prescription drug without a valid, error-free and unambiguous prescription.

PCS. 2. The holder of the in § 1. 1, such authorization must inform the prescriber if the holder handle a prescription in cases where it has not been possible to get defects remedied or doubts clarified see. § 28 para. 2, first sentence.

PCS. 3. The pharmacy and the holder of the in § 1. 1, such authorization must document referred to in paragraph. 1 and paragraph. 2 mentioned expeditions. The documentation shall be stored for 2 years, but in five years by supplying medicinal products to animals, see. § 18 paragraph. 1 pharmacist. The holder of the in § 1. 1, such authorization should be at the business address (main address) retain the record for 5 years, see. § 18 paragraph. 1.

§ 30. If a pharmacy is aware that several prescribers prescribe drugs for the same patient, and this may pose health risks to the patient, the pharmacy can orient receptudstederne the pharmacy's handling of a prescription, including the prescriber's name, patient name and CPR number ., as well as drug name, strength and dosage.

PCS. 2. The pharmacist must be able to document the course of action and the reasons for that receptudstederne has been informed about the expedition.


§ 31. The pharmacy and the holder of the in § 1. 1, such authorization may disclose an amount that differs by up to 1/10 of the prescribed amount. If the drug belongs dispensing group 'B' in accordance. § 63 paragraph. 4, or if the drug is not a prescription, the pharmacy can dispense a pack size which differs by up to 1/4 of the prescribed amount. If the drug belongs dispensing group "BP" or "BPK" see. § 63 paragraph. 12 and paragraph. 14, the pharmacist and proprietor of the in § 1. 1 authorization referred to extradite a pack size which differs by up to 1/4 of the prescribed amount.

PCS. 2. If the prescriber by underlining the prescribed amount has indicated that this should not be excluded, pharmacist and owner of the in § 1. 1 authorization referred to extradite an amount equal to the ordination. Differ the prescribed amount from the pack sizes available on the market, the pharmacist and proprietor of the in § 1. 1 authorization referred to extradite the packing or the seals, which is closest to the prescribed amount, see. Paragraph. 1.

PCS. 3. If the prescriber has indicated that the prescription can be executed multiple times with a fixed time intervals and pharmacist and proprietor of the in § 1. 1 authorization referred to extradite an amount that differs from the prescribed amount, shortened or extended time gap proportionately.

PCS. 4. The total quantity supplied must as far as possible to the total prescribed amount.

§ 32. If a drug dose should be packed, cf. Order on dose dispensing of drugs, the pharmacy can dispense the drugs, according to the dosing card will be used during the period in which the dose packaged.

§ 33. Drugs for individuals or animals to the pharmacy or the holder of the in § 1. 1 authorization referred to with the following information on the package:

1) The person's name or the species and its owner's name and the CHR number of animals in animal husbandry with CHR number.

2) The child's age, if the child has not yet been provided with medical card.

3) User's Guide, see. § 8 paragraph. 1 and § 17 paragraph. 4.

4) Date of the expedition.

5) The name of the pharmacy or the holder of the in § 1. 1, such authorization.

PCS. 2. Pharmaceuticals for use in prescription issuer's practice of pharmacy or the holder of the in § 1. 1 authorization referred supplied to in paragraph. 1 pt. 4 and 5, said information and prescriber's name.

PCS. 3. Drugs for distributing doctors and veterinarians, as well as not distributing doctors to re-extradition should the pharmacist or the holder of the in § 1. 1 authorization referred supplied to in paragraph. 1 pt. 4 and 5 that information.

PCS. 4. The information under paragraph. 1-3 should be applied to product packaging must be legibly printed or typed on a label affixed to the packaging. If the package consists of several parts, the label whenever possible placed inside the packaging.

PCS. 5. The rules in paragraphs. 1-4 does not apply to dose dispensed drugs.

§ 34. If a drug prescription issuer's instructions should bear the warning that it may impair the ability to drive or operate hazardous machinery, see. § 14 paragraph. 3, the pharmacy must apply warning symbol in the form of a red equilateral triangle, cf. Order on labeling etc. of drugs.

§ 35. The pharmacy and the holder of the in § 1. 1, such authorization shall be at each handling a prescription indicate on the prescription:

1) Date of dispatch.

2) Examinees or discontinued drug.

3) Surrendered or withdrawn amount.

4) The name of the pharmacy or the holder of the in § 1. 1, such authorization.

§ 36. Along with a prescription prescribed drug, the customer must be provided with a receipt or, if this is not possible, other documentation with the following information:

1) Customer CPR number. or fictitious Social Security no., cf. Order on the Central Reimbursement Register (CTR).

2) Expedition Number.

3) Date of dispatch.

4) The pharmacy's name.

5) Medicines (name).

6) Consumer price divided into patient share and public interests, including reimbursement from the region.

7) Grant price.

8) Balance at CTR calculated in reimbursement rates before dispatch of the prescription.

9) End of eligibility period in CTR.

§ 37. When not to provide multiple drugs in a prescription, the pharmacist or the holder of the in § 1. 1 authorization referred providing prescription with an endorsement that it is canceled.


PCS. 2. Telephone and fax prescriptions are not covered by the preceding paragraph. 1 unless they are dispensed from the pharmacy or the holder of the in § 1. 1, such authorization.

PCS. 3. The pharmacy and the holder of the in § 1. 1, such authorization may be required to disclose handled prescription forms to the customer. If a prescription containing prescription issuer CPR no., This must be deleted before prescription form disclosed.

§ 38. The pharmacist must dispense the cheapest drug in the group of pharmacy-only medicinal products referred to. Medicines Act § 60 paragraph. 1, and the vaccines according to Annex 1 and Annex 2 to replace the prescription (substitution).

PCS. 2. Includes prescribing more drugs with the same name (directly distributed and parallel imports) paragraphs. 1 correspondingly.

PCS. 3. Paragraph. 1 shall not apply if the prescriber explicitly on the prescription states that there should be no substitution, see. § 42 paragraph. 1.

PCS. 4. Paragraph. 1 may be waived if the following conditions are met:

1) The price difference between the cheapest drug in the group and the prescription is less than:

a) 5 kr., where the cheapest drug in the group costs 100 kr. or less

b) 5 per cent. the price of the cheapest medicine if the cheapest drug in the group costs more than 100 kr., but less than 400 kr., or

c) 20 kr., where the cheapest drug in the group costs 400 kr. or more.

2) There exists for dose dispensing of drugs for named users a special situation where dose dispensing of the cheapest drug in the group can not be done mechanically, see. Pharmacy Act § 11 paragraph. 1 pt. 10

3) There exists for dose dispensing of drugs to patients treated in primary care, cf. Order on dose dispensing of drugs, § 1. 2, no. 3, a situation where the price difference between the cheapest drug in the group and the prescription is less than 10 per cent. calculated using the cheapest drug unit in the group regardless of package size.

PCS. 5. The calculation under subsection. 4, no. 1, used consumer prices, cf. Order on calculating consumer prices for pharmacy-only medicinal products and pharmacy-only OTC medicines etc. Includes prescribing more drugs with the same name (directly distributed and parallel imports), calculated the price difference compared to what the medicines prescribed by pharmacist intends to disclose.

PCS. 6. Notwithstanding paragraph. 1-5, the user can request to receive the prescribed drug or any drug in a class of medicines which, according to Annex 1 and Annex 2 to replace the prescription. This does not apply if the prescriber has expressly stated on the prescription that there should be no substitution, see. § 42 paragraph. 1. dose dispensing of drugs for named users must desire to receive a particular drug, see. 1st clause., Be made later by placing an order or reorder the receptekspederende pharmacy.

§ 39. If it is cheaper for the user to obtain the prescribed drug or a drug that can substitute for the prescription, see. § 38 paragraph. 1, in the form of several similar smaller packages, the pharmacy must inform the user about it, see. However paragraph. 2 and 4. The user can choose to receive the prescribed package size or more smaller packages.

PCS. 2. The pharmacy can not to inform the user in accordance with paragraph. 1 if

1) the price difference between the prescribed package size and multiple smaller packages is below 5 kroner, or

2) delivery of several smaller packages involves a significant risk that the drug will be misused.

PCS. 3. The provisions of § 31 of how much the dispensed quantity may deviate from the prescribed, also applies to the delivery of several smaller packages under paragraph. 1.

PCS. 4. Paragraph. 1-3 does not apply to medicines in dispensing group "HF", "HX", "CR", "LIMITED", "A § 4 LIMITED", "premix", "AP", "BP" and dispensing group "APK" and "BPK" when the drug is dispensed for the treatment of livestock.

§ 40. If the prescription is included in Medicine Prices under dispensing group "HF" and "HX", the pharmacy can dispense the cheapest drug in the group of medicines that according to Annex 1 and Annex 2 to replace the prescription, see. However paragraph. 3.


PCS. 2. Is the prescription included in Medicine Prices under dispensing group "premix", "AP" or "BP" or dispensing group "APK" or "BPK" when it is dispensed for the treatment of production animals, the pharmacist and proprietor of the in § 1, PCS. 1 authorization referred to extradite any drug in a class of medicines which, according to Annex 1 and Annex 2 to replace the prescription, see. However paragraph. 3.

PCS. 3. The pharmacy and the holder of the in § 1. 1, such authorization shall not undertake substitution if the prescriber has expressly stated on the prescription, that this must not take place, see. § 42 paragraph. 1.

§ 41. If a drug is prescribed for dose dispensing, both available in pack sizes included in Medicine Prices under dispensing group "HF" or "HX" and contents that are pharmacy-only, the prescription processed in accordance with § 38.

§ 42. If the prescriber on the prescription states: "Neither S ', the pharmacist and proprietor of the in § 1. 1, this authorization is not substitute the prescribed drug with another drug.

PCS. 2. Includes prescribing more drugs with the same name (directly distributed and parallel imports) without the prescription has made a clear choice of treatment, including quoting dealer or lot number, the pharmacy and the holder of the in § 1. 1 authorization referred disregard opt endorsement.

PCS. 3. Prescription Issuer's rejection of substitution shall not affect the delivery of the prescription in several similar smaller packages pursuant to § 39 paragraph. 1.

§ 43. The pharmacy and the holder of the in § 1. 1, such authorization should write down the phone prescriptions on forms labeled "Phone Prescription '.

PCS. 2. The pharmacy and the holder of the in § 1. 1, such authorization may only process the fax and telephone prescriptions once. For pharmacies apply it not when prescribing methadone to patients in long-term treatment, see. § 15 paragraph. 4.

PCS. 3. The pharmacy and the holder of the in § 1. 1, such authorization may only attend to fax prescriptions received at one of the pharmacist owned pharmacy unit or on one of the license holder's business locations.

Chapter 6

Storage and transmission of prescriptions for narcotic drugs

§ 44. Prescriptions of drugs under § 4 shall be subject to special monitoring to be stored in the pharmacy at least 1 year after they are processed. Instead of the original prescription pharmacy can keep a copy of the prescription incl. processing information.

Chapter 7

Medicine requisitions

§ 45. medicine requisitions understood orders (requisitions) at the pharmacy or hospital pharmacy of:

1) Drugs for medicine depots (central warehouses in hospitals and other care institutions).

2) Prescription medicines for hospital wards and departments at similar institutions.

3) Prescription medicines for

a) municipal treatment centers for drug addicts see. Health Law § 142, and

b) other municipal council, regional council or private institutions providing treatment, the local council has concluded agreements on medical treatment of drug abusers.

4) Drugs for the specific purpose set out in §§ 52-62.

§ 46. Medicine requisitions must bear the date the claimant's signature and printing or stamping information relating to the client (the depot, division, etc.) the name, address and telephone number. Medicine requisitions from the drug depot and hospital departments should also bear hospital code or hospital code.

PCS. 2. Signature on the in § 45, no. 1, 2 and 3, requisitions may be omitted in cases where the booking is made via a medicinrekvireringssystem, by agreement between the pharmacy or hospital pharmacy and the person responsible for rekvireringen is arranged so that rekvireringen can take place in a safe manner. Requisitions on drugs covered by § 4 shall always bear the client's signature.

PCS. 3. Medicine requisitions must contain the information specified in § 7, paragraph. 1.

§ 47. The in § 45, no. 1, 2 and 3 shall medicine requisitions must be in writing, electronically, by fax or by telephone.

PCS. 2. The § 45, no. 4, said medicine requisitions must be submitted as prescribed in § 52, § 54, § 55, § 57, § 58, § 59 and § 62.


§ 48. By electronic transfer, indtelefonering or sending the fax of medicine requisitions, the provisions of § 20 paragraph. 2 and 3, § 22, stk. 2 and § 23 paragraph. 3, correspondingly.

§ 49. The in § 45, no. 1, said requisitions can only be released by the depot manager or deputy.

PCS. 2. The § 45, no. 2 and 3, said requisitions must be given by a doctor or dentist.

PCS. 3. Notwithstanding paragraph. 2, the doctor or dentist in charge of the department of electricity, however, decide to requisition of drugs that are not subject to special monitoring under § 4, in a certain degree, can be made by an authorized person who is not doctor or dentist.

PCS. 4. In § 45, no. 4, said requisitions can be delivered by midwives, nurses, dental hygienists, masters and shipowners, manufacturers of lifeboats, managers of service stations that carry out inspection of lifeboats and life rafts, persons who are authorized to order medications for ambulances, as well as managers of companies engaged in welding work, see. § 52, § 54, § 55, § 57, § 58, § 59 and § 62.

§ 50. The pharmacy or hospital pharmacy must organize work procedures and routines so that there is proper control and assurance that medicine requisitions are handled properly and that the receiver as necessary informed of the pharmaceutical supply use, etc. Medicine requisitions are subject to the rules of § 26 , § 27 paragraph. 3 and paragraph. 4 and § 31 paragraph. 1. § 31 paragraph. 1, except for requisitions to the ship's medicine chests.

PCS. 2. If a medicinrekvisition not drafted in accordance with the provisions of this chapter, pharmacy or hospital pharmacy search this rectified. If it is not possible to have any defects remedied or doubts clarified, the requisition not be dispatched unless

1) it must be assumed that one or more patients can suffer serious medical damage if the requisition is not processed, and treatment of patients therefore have to be postponed or

2) there is no reasonable doubt about the content requester wanted to give the requisition.

PCS. 3. The pharmacy or hospital pharmacy must document the company after paragraph. 2. documentation shall be kept at the pharmacy or hospital pharmacy in 3 years.

§ 51. Medicine requisitions must of pharmacy or hospital pharmacy supplied with the pharmacy's name and date of expedition.

PCS. 2. The drugs must of pharmacy or hospital pharmacy supplied with the pharmacy or hospital pharmacy's name and date of expedition.

PCS. 3. Medicine requisitions may only be processed once.

Requisitions for special purposes

midwives

§ 52. midwives may in writing request the following drugs for use in practice:

1) Tablets containing 0.125 mg methylergometrine.

2) Solution for injection containing methylergometrine 0.2 mg / ml.

3) injection containing oxytocin 10 IU / ml.

4) Solution for injection containing mepivacaine 5 mg / ml and 10 mg / ml.

5) Solution for injection containing phytomenadione 10 mg / ml in ampoules of 0.2 ml.

PCS. 2. midwives may exceptionally request in paragraph. 1 mentioned medicines by telephone. The provisions of § 23 paragraph. 2 and 3 shall apply mutatis mutandis.

§ 53. The in § 52 paragraph. 1, said drugs pharmacy must provide the following information:

1) The midwife's name.

2) The pharmacy's name.

3) Date of dispatch.

4) endorsement: "For use in practice."

nurses

§ 54. Nurses may in writing request adrenaline injection 1 mg / ml in ampoules of 1 ml for use in practice.

PCS. 2. in paragraph. 1 said drug pharmacy must provide the following information:

1) The nurse's name.

2) The pharmacy's name.

3) Date of dispatch.

4) endorsement: "For use in practice."

Hygienists

§ 55. Authorised hygienists with the pursuit of self-employment and to bring infiltration (unrestricted A-license in accordance with § 2 or § 18 paragraph. 1 or 3 of the Act on dental hygienists) can be provided in the exercise of the dental care business writing request the following drugs for use in practice:

1) local anesthetics for injection containing mepivacaine without vasoconstrictor: for injection 30 mg / ml, tubules a 1.7 ml or 1.8 ml.

2) local anesthetics for injection containing lidocaine, added vasoconstrictor (catecholamine): injection 2 per cent., 1 ml containing 20 mg lidocaine and 12.5 micrograms adrenaline tubules a 1.8 ml.


3) local anesthetics for injection containing lignocaine, added vasoconstrictor (catecholamine): injection 1 ml containing 20 mg mepivacaine and 10 micrograms adrenaline tubules a 1.7 ml.

4) local anesthetics for injection containing prilocaine, added vasoconstrictor (felypressin): injection 3 pct., 1 ml containing 30 mg prilocaine and 0.54 micrograms felypressin, tubules a 1.8 ml.

5) local anesthetics for injection containing articaine, epinephrine added: injection 4 per cent., 1 ml containing 40 mg articaine and 5 micrograms adrenaline tubules á1,7 ml.

6) local anesthetics for injection containing articaine, epinephrine added: injection 4 per cent, 1 ml containing 40 mg articaine and 10 micrograms adrenaline tubules a 1.7 ml.

7) Epinephrine Injection 1 mg / ml in a 1 ml ampoule.

8) Preparations containing sodium fluoride:

a) Dental suspension of sodium fluoride 50 mg / mL.

b) Suspension in Dental varnish containing sodium fluoride 60 mg / ml calcium and 60 mg / ml.

c) Resolution for mouthwash 0.2 per cent. sodium fluoride.

d) Resolution for brushing of teeth 2 per cent. sodium fluoride.

PCS. 2. Authorized hygienists with access to engaging in business without the right to bring infiltration (limited B-authorization according to § 18 paragraph. 2 of the Act on dental hygienists) can be provided in the exercise of the dental care business written request in paragraph. 1, no. 8, said drugs for use in practice.

§ 56. § 55 of the said drugs pharmacy must provide the following information:

1) Dental's name.

2) The pharmacy's name.

3) Date of dispatch.

4) endorsement: "For use in practice."

Masters, owners and manufacturers of lifeboats, etc.

§ 57. Masters and shipowners may in writing request a prescription for medicine chests, as their vessels in accordance with applicable rules must bear.

§ 58. Manufacturers of survival craft and managers of service stations shall inspect the survival craft may, in writing and on presentation of authorization from the Danish Medicines Agency request a prescription for medicine chests that survival craft in accordance with applicable rules must be provided with .

PCS. 2. Requisitions on drugs for survival craft shall contain information about the survival craft make and number.

§ 59. Regions and municipalities and companies by arrangement make ambulances available to regions can for the supply of ambulances belonging to the writing request in the Annex to the Executive Order on the planning of the pre-hospital care and training of ambulance personnel, etc. those products.

PCS. 2. Requisition of medicines in accordance with paragraph. 1 can only be made by persons, the regional council, the local council or the company's management has delegated this responsibility. The Regional Council, local council or the company's management shall notify pharmacist who is authorized to order medications on the region, the municipality or the company's behalf.

§ 60. The pharmacy must provide the medicines supplied under requisition in accordance with § 57, § 58 and § 59, with information on the pharmacy's name and date of expedition, and as far as the medicinal products supplied in accordance with § 57 and § 58, together with any special information which is required under the current rules on ship's supply of drugs.

§ 61. handled medicine requisitions on drugs for the ship's medicine chests must be kept at the pharmacy for 2 years.

Welding Companies

§ 62. Managers of companies dealing with welding work may obtain an eye ointment containing cinchocaine 0.5 per cent. in endosisbeholdere.

PCS. 2. The pharmacy must provide the drug to be provided with information on the pharmacy's name and date of expedition.

Chapter 8

Delivery Groups

§ 63. The Danish Medicines Agency classifies prescription drugs in the following groups:

1) Dispensing »A § 4 '.

2) Dispensing 'A'.

3) Dispensing 'B'.

4) Dispensing 'LIMITED'.

5) Dispensing »NB-S '.

6) Dispensing »A § 4 LIMITED '.

7) Dispensing »A § 4-NB-S '.

8) Dispensing 'R'.

9) Dispensing 'premix'.

10) Dispensing "AP"

11) Dispensing "BP"

12) Dispensing "APK"

13) Dispensing "BPK"

14) Dispensing GA

15) Dispensing GB


PCS. 2. Drugs in dispensing group 'A § 4 "must pharmacist extradite once on the same prescription, see. However, § 15

PCS. 3. Drugs in dispensing group 'A' must pharmacist extradite once on the same prescription, unless the delivery is done in several small portions at a time.

PCS. 4. Drugs in dispensing group 'B' must pharmacist dispense once on the same prescription, unless the prescriber has indicated on the prescription, how many times and for what time intervals further extradition may take place.

PCS. 5. Drugs in dispensing group 'LIMITED' must pharmacist extradite to hospitals. The drugs should be subject to the provisions for medicinal products in dispensing group 'A'.

PCS. 6. Drugs in dispensing group 'NB-S' must pharmacist extradite to hospitals or on the order of specific medical specialists. Medicines Agency sets for each drug, the specialists must prescribe the drug. The drugs should be subject to the provisions for medicinal products in dispensing group 'A'.

PCS. 7. Drugs in dispensing group 'A § 4 LIMITED' must pharmacist extradite to hospitals. The drugs should be subject to the provisions for medicinal products in dispensing group 'A § 4'.

PCS. 8. Drugs in dispensing group 'A § 4-NB-S' must pharmacist extradite to hospitals or on the order of specific medical specialists. Medicines Agency sets for each drug, the specialists must prescribe the drug. The drugs should be subject to the provisions for medicinal products in dispensing group 'A § 4'.

PCS. 9. Drugs in dispensing group 'R' is covered by a risk management program referred to. Medicines Act § 62 and must only be prescribed and dispensed accordingly. The detailed rules for the risk management program is available on the Agency's website.

PCS. 10. Drugs in dispensing group 'premix' should pharmacist and proprietor of the in § 1. 1 authorization referred to only hand over the prescription from a veterinarian to feed mills Medicines Agency authorized to manufacture medicated feed. The drugs should be subject to the provisions for medicinal products in dispensing group 'B'.

PCS. 11 Drugs in dispensing group "AP" must be handed to the pharmacist who has given Medicines Agency announcement according to § 12 a paragraph. 1 of the Law on Pharmacies, and holders of the in § 1. 1, such authorization. The drugs should be subject to the provisions for medicinal products in dispensing group "A".

PCS. 12. Drugs in dispensing group "BP" must be handed to the pharmacist who has given Medicines Agency announcement according to § 12 a paragraph. 1 of the Law on Pharmacies, and holders of the in § 1. 1, such authorization. The drugs should be subject to the provisions for medicinal products in dispensing group "B".

PCS. 13 Drugs in dispensing group "APK" be using for production supplied only at the pharmacies that have given Medicines Agency announcement according to § 12 a paragraph. 1 of the Law on Pharmacies and holders of the in § 1. 1, such authorization. It is a condition to ensure that supply can legally take place, the recipe is applied "for production". The drugs should be subject to the provisions for medicinal products in dispensing group "A".

PCS. 14 Drugs in dispensing group "BPK" be using for production supplied only at the pharmacies that have given Medicines Agency announcement according to § 12 a paragraph. 1 of the Law on Pharmacies and holders of the in § 1. 1, such authorization. It is a condition to ensure that supply can legally take place, the recipe is applied "for production". The drugs should be subject to the provisions for medicinal products in dispensing group "B".

PCS. 15 Drugs in dispensing groups 'AP' and 'BP' to horses or rabbits that are not held for business purposes, including the production of eye may be also dispensed by pharmacies, who have not given Medicines Agency announcement according to § 12 a paragraph. 1 of the Law on Pharmacies.

PCS. 16 Drugs in dispensing group GA shall dispensed in pharmacies and by holders of the in § 1. 2, that authorization. The drugs should be subject to the provisions for medicinal products in dispensing group A

PCS. 17 Drugs in dispensing group GB must be handed in pharmacies and by holders of the in § 1. 2, that authorization. The drugs should be subject to the provisions for medicinal products in dispensing group B.


§ 64. Medicinal products not subject to prescription under § 2. 1, or § 3 and which prescribed a prescription should be provided on the legal status group 'B'.

§ 65. Medicinal products which have not been granted authorization, including extemporaneous drugs should be provided on the legal status group 'A', see. However paragraph. 2 and § 66.

PCS. 2. The paragraphs. 1 said drugs should be subject to legal status group 'A § 4' if they contain:

1) drugs that are included in Appendix B of Annex 1 to the Order on drugs in quantities that are not exempted from the provisions of that notice

2) possible salts and simple derivatives with similar properties as the no. 1 above drugs or

3) substances included in Annex 3 to this Order.

§ 66. In determining which drugs should be attributed to dispensing group 'LIMITED', 'NB-S "," A § 4 LIMITED' and 'A § 4-NB-S', emphasis is placed on whether the drugs | ||
1) have specific pharmacological properties or in the interest of public health should be reserved for treatment in hospitals,

2) be used to treat diseases diagnosed in hospitals, etc., or

3) notwithstanding that they are designed for ambulatory use, requires special expertise and special supervision.

§ 67. It appears from Medicine Prices, which the dispensing a drug is placed, including the medical specialties that are qualified to prescribe medicines in dispensing group 'NB-S "and" A § 4-NB-S'.

Chapter 9

Revocation, dispensing without guarantee of payment and exemption

§ 68. If a drug withdrawn from the market, the pharmacies and holders of the in § 1. 1 authorization referred to notify distributing doctors and veterinarians, hospitals and similar institutions, they have supplies to that effect.

§ 69. Pharmacies must supply medicinal products to a few days of use without any security for payment when the doctor indicates on the prescription,

1) that the medicines needed immediately and

2) who is expected later to pay for the drugs.

§ 70. The Danish Medicines Agency may in special cases and under conditions to be determined in each case, exclude from the provisions of this Order or impose stricter requirements.

Chapter 10

Criminal and entry into force

§ 71. Penalty that violate § 7 paragraph. 2, 3rd clause., § 18, § 21, second paragraph., § 23 paragraph. 4 and 5, § 24 paragraph. 2, 26, paragraph. 1, §§ 27-29, § 30 paragraph. 2, § 31 paragraph. 2, § 33 paragraph. 1-4, §§ 34-36, § 37 paragraph. 1 and 3, § 38 paragraph. 1, § 39 paragraph. 1, § 40 paragraph. 3, § 41, § 42 paragraph. 1, § 43 paragraph. 1 and paragraph. 2, first sentence. And paragraphs. 3, § 44, § 50, § 51, § 53, § 54 paragraph. 2, § 56, § 60, § 61, § 62 paragraph. 2, § 63 paragraph. 2-14 and paragraphs. 16-17, § 64, § 65, § 68 and § 69.

PCS. 2. There can be imposed on companies etc. (legal persons) under the rules of the Penal Code Chapter 5.

§ 72. This Order shall enter into force on 1 January 2012.

PCS. 2. At the same time, Executive Order no. 155 of 20 February 2007 on prescriptions.

Medicines Agency, December 15, 2011
Jytte Lyngvig
/ Anne-Marie Vangsted