Dispensation right

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The right to dispense or the freedom to dispense is understood as the legal permission to manufacture, mix, store and dispense pharmaceuticals subject to pharmacy and prescription requirements - which is equivalent to running a pharmacy .

According to the so-called “ Edict of Salerno ”, the areas of activity of pharmacists and human physicians are separated; the latter therefore have no right of dispensation in Germany. An exception to the pharmacy monopoly , however, is the veterinary dispensing right, which is historically guaranteed by an addendum assigned to the Edict of Salerno. In the further history there are service contracts that make this regulation as customary law for professional groups with knowledge of individual animal species, such as B. farriers , shepherds , hunters or skinners take over. From the beginning of the 19th century legal regulations followed, the continuation of which can be found in the currently applicable Medicines Act (AMG) .

The legal basis for dispensing law in Germany is the Medicines Act. For veterinarians, the ordinance on veterinary house pharmacies (TÄHAV) also applies .

Veterinary dispensing law

This section presents the situation in Germany . Help us to describe the situation in other countries.

Veterinarian's right

A licensed veterinarian may use pharmacy and prescription drugs

  • obtain from wholesalers or manufacturers for use on animals treated by them ( Section 47 (1) No. 6 AMG)
  • hand over to the owner of the animals he has treated ( Section 43 Paragraphs 4 and 5 AMG)
  • for use on animals treated by him in a veterinary house pharmacy ( § 13 para. 2 No. 3 AMG, § 21 para. 2 No. 4 AMG) and store ( § 9 TÄHAV)

This exception from the pharmacy monopoly only applies if the animals are properly treated. It means that

  1. the animals or the animal population have been examined to an appropriate extent and in accordance with the rules of veterinary science before the medicinal product is used, and that
  2. the use of the medication and the success of the treatment are monitored by the veterinarian.

Conditions for exercising the veterinary dispensation right

Only a licensed veterinarian is allowed to keep a veterinary medicine cabinet and thus exercise the right to dispense. Conversely, if a veterinarian loses his license to practice medicine, he is no longer allowed to keep a veterinary medicine cabinet and is also no longer allowed to exercise the right to dispense.

The veterinary house pharmacy must first be reported to the competent authority, often to the veterinary office ( Section 67 (1) AMG) and is then checked by them at regular intervals (approx. Every 2 years) ( Section 13 (4) TÄHAV). The veterinary medicine cabinet must have one or more suitable operating rooms, which must be designed in such a way that they enable the correct manufacture, testing, storage and dispensing of the drugs. This means that they must be in a proper structural and hygienic condition, in particular be clean, dry and easily ventilated and must not be used for purposes unrelated to practice ( Section 3 TÄHAV). The devices that are required for the proper operation of the veterinary medicine cabinet in question must be in perfect condition ( Section 4 (1) TÄHAV). In addition, the relevant legal provisions on the trade in drugs, narcotics, the drug price ordinance and, if the nature and scope of the activity is required, the official edition of the pharmacopoeia in the current version must be available in the operating rooms ( Section 4 (2) TÄHAV). The veterinarian must store all medicines in operating rooms at a single location (exceptions apply to zoological gardens, animal shelters, laboratory animal facilities, veterinary clinics, universities and insemination centers) in a clear arrangement, separated from other means and provided with permanent and clear labels, so that they are flawless Quality is retained and they are not accessible to unauthorized persons ( § 9 TÄHAV). The amount of veterinary drugs stored in the veterinary house pharmacy and carried in the external practice (i.e. in the car) is limited to what is absolutely necessary to ensure the medical care of animals ( Section 9 (1) and Section 11 (2) TÄHAV).

Furthermore, the veterinarian must first notify the Federal Opium Agency in writing of participation in narcotics traffic in accordance with Section 4 (3) BtMG . On the basis of this notification, he is assigned his personal BtM number, which he can use to prescribe narcotics .

Another requirement that the veterinarian must observe relates to the selection of the drug for treatment. The drugs used must generally be approved for the animal species treated and for the disease to be treated . Only in the event of a therapeutic emergency in which no drug that meets the criteria is available, the veterinarian may switch to other drugs. With this so-called reallocation of drugs, the veterinarian is bound by the legally prescribed reallocation cascade. According to this, he must primarily use veterinary medicinal products approved in Germany before he z. B. may switch to medicinal products for humans approved in Germany or European veterinary medicinal products ( Section 56a (2) AMG).

Legislation for the exercise of the veterinary dispensation right

As part of the dispensing right and the operation of a veterinary house pharmacy, the veterinarian must comply with numerous laws, regulations and guidelines in addition to the Veterinary House Pharmacy Ordinance (TÄHAV). On the one hand, the general pharmaceutical regulations applicable to pharmacies, such as the Medicines Act (AMG), the Ordinance on the Prescription of Medicines (Medicinal Prescription Ordinance - AMVV), the Ordinance on pharmacy-only and over-the-counter medicines and the Medicines Price Ordinance must be observed.

The Animal Health Act (TierGesG) and the ordinance on sera, vaccines and antigens according to the Animal Health Act are authoritative for the handling of vaccines . For prescribing drugs that are Narcotics Act (Narcotics Act) and the Narcotics Prescription Order (BtMVV) and the Narcotics Domestic Trade Regulation (BtMBinHV) is important.

The Food and Feed Code (LFGB), the Ordinance on Substances with Pharmacological Effects , the Feed Ordinance (FMVO), the Animal Keeper Drug Application and Detection Ordinance and the European Regulations Regulation (EC) No. 470/2009 , Regulation (EC) No. 37/2010 , Regulation (EC) No. 851/1981 , Regulation (EC) No. 852/1981 , Regulation (EC) No. 316/1993 , Regulation (EC) No. 74/2003 and Regulation (EC) No. 1950/2006 .

literature

  • Erwin Deutsch, Rudolf Ratzel, Hans-Dieter Lippert: Commentary on the Medicines Act (AMG). 3rd edition, Gabler Wissenschaftsverlage, 2010, ISBN 978-3-6420-1454-3 , p. 9 ( limited preview in the Google book search).

Web links

Individual evidence

  1. ↑ http://www.apotheker.at/internet/oeak/NewsPresse_1_0_0a.nsf/6caaa1ae0b9e4fa5c1256a7d0054127a/2aa16a86543cc370c125710600467bf0!OpenDocument .
  2. ↑ http://www.tieraerztekammer-sachsen.de/index.php?p=Con&s1=Informationen&s2=Dresdner-Gesprächsrunde:-Tierärzte-und-das-Dispensierrecht .
  3. ↑ Ordinance on veterinary house pharmacies (TÄHAV)
  4. ↑ http://www.lgl.bayern.de/tiergesundheit/tierarzneimittel/dispensierrecht/index.htm