Regulation On The Wholesale Trade And The Drug Agency

Original Language Title: Verordnung über den Großhandel und die Arzneimittelvermittlung

Read the untranslated law here: http://www.gesetze-im-internet.de/amgrhdlbetrv/BJNR023700987.html

Regulation on the wholesale trade and the drug agency (drug trade regulation - at HandelsV) at IM HandelsV Ausfertigung date: 10.11.1987 full quotation: "drug trade regulation of 10 November 1987 (BGBl. I S. 2370), most recently by article 2 of the law of 7 August 2013 (BGBl. I S. 3108) has been changed" stand: last amended by art. 2 G v. 7.8.2013 3108 for more information on the stand number you find in the menu see remarks footnote (+++ text detection from) : 1.1.1988 +++) (+++ changes due to EinigVtr cf. § 11 +++) heading: IdF d. Article 7 No. 1 G v. 19.10.2012 2192 mWv 2.1.2013 input formula to reason - article 12 para 1 Nos. 1 and 2 of the medicines Act of 24 August 1976 (BGBl. I p. 2445, 2448), whose article 1 through article 1 of the law of 16 August 1986 (BGBl. I p. 1296) has been modified , is in agreement with the Federal Ministers for economy, labour and Social Affairs and for nutrition, agriculture and forestry and - § 54 para 1 to 2a of the medicines Act, its heading and paragraph 1 sentence 1 and paragraph 2 No. 1 by article 1 of the above-mentioned Act of August 16, 1986 and its paragraph 1 sentence 2 in accordance with article 1 of the third Zuständigkeitsanpassungs regulation of 26 November 1986 (BGBl. I S. 2089) has been changed and its paragraph 2a by article 1 the Act of February 24, 1983 (BGBl. I S. 169) is been inserted, is in agreement with the Federal Ministers for economic, environmental, nature conservation and nuclear safety and for nutrition, agriculture and forestry with the consent of the Federal Council decreed: article 1 scope this Regulation shall application on farms and facilities, insofar as they do not drive wholesale trade in medicinal products as far as according to § 1 para 2 of pharmaceuticals and active ingredient production regulation by November 3, 2006 (BGBl. I S. 2523) , whose provisions apply. Regulation applies also apply to medicinal agents within the meaning of § 4 paragraph 22a of the medicines Act, as far as this Regulation determines this.

§ 1a quality assurance system establishments and facilities must comply with the EU guidelines on good distribution practice of medicinal products and for this operate a functioning quality management system according to the nature and scope of the activities carried out, involving the active participation of the Management Board. The quality assurance system must ensure in particular that medicinal products only for legitimate companies and institutions are involved and delivered only to those, the quality of medicines is not adversely affected during storage and transport, avoids confusion and is a sufficient system of traceability, including the implementation of a callback. The person in charge ordered pursuant to section 2 para 1 must ensure in particular that reference and delivery of pharmaceutical products in accordance with the sections 4a and 6 are carried out and checked the written procedures on a regular basis, if necessary, adapted to the level of science and technology and followed.

§ 2 staff (1) who operates a drug wholesaler, has to purchase at least one person, who is responsible for the correct operation, in particular for compliance with the provisions of §§ 1a, 4-7 c of this regulation for each facility.
(2) personnel must be available with sufficient professional qualifications and in sufficient number to enable compliance with the requirements of this regulation. It may be employed only in accordance with his training and his knowledge and to teach about the care provided when dealing with medicines regularly.

§ 3 finish, size and equipment of the premises (1) the premises must ensure proper operation of the wholesale trade in medicines according to type, size, number, location, condition and equipment.
(2) the premises must have suitable climatic conditions and must be protected by appropriate measures against unauthorised access.
(3) the equipment used should be easy to clean and must be maintained.
(4) premises and their facilities must be cleaned regularly. In operating rooms, medicines are racked, packed and marked, to do after a hygiene plan in which in particular is set: 1 the incidence of the measures, 2. carried out cleaning procedures and the equipment to be used and tools, 3rd with the supervision entrusted persons.

§ 4 containers, packing and marking of medicines (1) only such medicinal products for the purposes of the levy be transferred to or packaged, whose quality required is determined.
(2) by spatial or temporal separation of individual operations or by other appropriate technical or organisational measures precaution shall be taken to avoid adverse interference of medicines, as well as confusion.
(3) medicinal products may be transferred only in containers or packaged that guarantee no longer as inevitable deterioration in the quality.
(4) pharmaceutical products, which are intended for use in humans and are not finished medicines, are allowed only in the traffic, if their containers and, if used, the outer casings are marked according to § 10 para 1 No. 1, 2, 4, 8 and 9 of the German medicines Act in legible font, in German and in a lasting way. Certain medicinal products which are not finished medicines, be allowed for use in animals only, if the containers and, where used, the outer wrappings with the details are provided after the pursuant to sections 10 and 11 of the medicines Act.

§ 4a subscription and redemption of medicinal products medicinal products (1) may be acquired only by companies entitled to the dispensing of medicinal.
(2) the deliveries are to review whether 1 containers are not damaged, 2. the delivery coincides with the order, 3. the supplier stating the issuing authority and date of issue has confirmed that it has the necessary permits, 4. the medicinal agent unless he is claimed, has undertaken the necessary indicator for the registration and 5th provided security features the authenticity of the medicinal prove that certain medicines according to § 10 paragraph 1 c of the German medicines Act in any adoption.
(3) as far as the drug obtained from an operation with a permit according to § 52a of the medicines Act or through a drug retailer, has the recipient whose adherence to the good distribution practices to convince.
(4) pharmaceutical products can be withdrawn from companies and institutions that have a permit according to § 52a of the medicines Act or under the pharmacy Act or that may otherwise be entitled to delivery to the consumer.

§ 5 storage are (1) medicinal products to store, that their quality is not adversely affected, and confusion be avoided. The temperature required for certain medicinal products is to ensure cooling facilities or other measures. Storage instructions must be followed.
(2) the storage containers must be such that the quality of the content is not affected. You must be provided with clear inscriptions which uniquely identify the content. As far as names by Decree No. 1 of the German medicines Act are prescribed according to § 10 para 6, these are to use. The content is to identify, as far as this is necessary to avoid confusion with additional information. Sentences 2 to 4 do not apply to storage containers properly labelled drugs be stored where.
(3) counterfeit medicines which are found in the distribution network, as well as are other non-traffic-enabled drug until a decision on the way forward, separated from traffic-enabled medicinal and secured to keep, to avoid confusion and to prevent unauthorized access. You must clearly not to sell certain drugs be marked as. On the occurrence of counterfeit medicines is immediately to inform the competent authority and the relevant marketing authorisation holder.
(4) pharmaceutical products, which are not marketable, be destroyed or, where is a return to the supplier intended to return.

§ 6 delivery (1) unless otherwise permitted by law, supplies of medicinal products only to companies and institutions must be carried out, who have a permit according to § 13 or section 52a of the medicines Act or a permit referred to in article 40 or a permit pursuant to article 77 of the Directive 2001/83/EC or a permit pursuant to article have 44 or a permit pursuant to article 65 of Directive 2001/82/EC or which are authorised for sale to the final consumer. Wholesalers supply medicinal products intended for use in humans, to persons domiciled outside the European Union or another Contracting State to the agreement on the European economic area, they have to make sure that the recipients are authorised according to the applicable laws and regulations of their State to get medicines to the wholesale trade or for sale to the public.
(2 sufficient documents include) deliveries, emerge from which in particular the date of delivery, the name and quantity of the medicinal product and name and address of the supplier and the recipient. The batch number of the corresponding medicinal product must be specified in the case of delivery to other enterprises and institutions that have a permit according to § 52a of the medicines Act, in addition. In addition must be confirmed, indicating the issuing authority and date of issue, that the supplier has a permit in accordance with section 52a of the medicines Act. The obligation to the additional indication of the batch number is also 1 distribution of medicines to pharmaceutical entrepreneur, hospital pharmacies and hospital serving pharmacies for the purposes of the supply of hospitals, 2. in the case of the distribution of blood preparations, Sera from human blood and preparations from other substances of human origin, as well as genetically manufactured blood components, the missing blood components replace also supplied to enterprises and institutions for sale to the final consumer , 3. in the case of submission of the application in animals of certain medicines, as well as 4 in the case of the delivery of medicines, must wear the security features within the meaning of § 10 paragraph 1 c of the medicines Act.
(3) during the transport of pharmaceutical products to ensure is to the delivery in the area of responsibility of the receiver for this, that no unauthorized access to the medicines and the quality of medicinal products is not affected.

§ 7 documentation (1) every reference and any distribution of medicines are records in the form of purchase / sales invoices, maintain in computerised form or in any other form, which contain the information pursuant to section 6 para 2.
(1a) (lapsed) (2) records are also to run over the filling and packaging of pharmaceutical products, as well as about the withdrawal, return or destruction of medicinal products which may; not be placed on the market There are information about the time, as well as type and quantity of the drug. The records are to provide ordered or a person designated by it by according to § 2 para 1 with name character.
(3) the records for at least five years after the last entry to keep paragraphs 1 and 2, as well as the evidence are according to § 47 para 1 b of the medicines Act. Blood preparations, Sera from human blood and preparations from other substances of human origin, as well as genetically manufactured blood components that replace missing components of blood, the records are referred to in paragraph 1 at least thirty years to save or store. You are to destroy or delete, if the storage or storage is no longer necessary. The records are kept longer than 30 years or stored, they are anonymous. The initial contents of a registration may be made using strike through nor otherwise illegible. No changes may be made, unaware of let if they in the original registration or later have been made.
(4) for storage of records on disks must in particular that the data for the duration of the retention period are available and can be made readable within a reasonable period of time be ensured.

§ 7a recall plan, recalls of medicines (1) who runs a pharmaceutical wholesale business, must have a recall plan, which ensures the implementation of any recall of a medicinal product which is carried out according to the competent authorities or of the marketing authorisation.
(2) the recall plan and the necessary organizational processes must be set in writing. Records must be made on the implementation of callbacks. § 7 para 3 shall apply mutatis mutandis.

§ 7 b withdrawal of medicines (1) is the operator of a medicinal wholesale delivered medicines from the receiver, so are back to store them separately from the stocks to make certain until a decision on its further use.
(2) if the withdrawn medicinal products according to the return medicines ineligible to transport or he does not provide details to the marketability, they are so as not marketable marked to make, to secrete and the destruction to feed. As far as a return to the pharmaceutical entrepreneur was arranged or agreed with this, they are to return after appropriate labelling.
(3) if the withdrawn medicinal products according to the return transport-capable medicines, they are about their further use of a test to take before deciding. The drug may be resumed only in the stocks destined for sale, if 1 the return occupied by business documents such as delivery notes and invoices, that he obtained from the pharmaceutical wholesale trade, 2. the return in writing that they since have been delivered properly stored and handled, didn't leave his responsibilities, in particular, 3. they are in the original containers and in proper condition , 4. they have a reasonable shelf life, 5. There are no details of the marketing authorisation or the competent authority through lack of transport capacity, no other evidence of a lack of transport are 6. These are the nature of the medicinal product, the required storage conditions and take into account the period elapsed since the delivery. This particularly applies to medicinal products with special requirements for the storage conditions.
(4) the examination and decision pursuant to paragraph 3 must be done by staff especially trained for this. The testing procedure and the organizational processes are writing to set.

§ make sure of 7 c self inspection (1) compliance with the requirements of this regulation, self inspections must be performed regularly. About the self inspection and then taken, records must be kept and stored.
(2) the person appointed pursuant to section 2 para 1 has to make sure drug related only by suppliers, who are authorized to trade in pharmaceutical products.

§ 8 service in times of crisis that competent authority may order the service for pharmaceutical wholesale companies, if and as long as the necessary supply of pharmacies and veterinary house pharmacies with drugs would otherwise seriously at risk. The arrangement must be limited in time; It may be extended.

§ 9 the sections 1a and 7a shall apply requirements to medicinal agents (1). Article 7, paragraph 1, 3 and paragraph 4 shall apply mutatis mutandis with the proviso that the records of the executed trade operations are to lead.
(2) the medicinal agent has to ensure that the approval - or approved drugs with which he is no. 726 / 2004 have an authorisation for the placing on the market in the area of application of the Act or approval under Regulation (EC).
(3) on suspicion of counterfeiting are immediately to inform the competent authority and the relevant marketing authorisation holder.

§ 10 offences any person within the meaning of § 97 para 2 No. 31 of the German medicines Act is, who intentionally or negligently 1 as the operator of a medicinal wholesale) contrary to article 2, paragraph 1, a person is not ordered or b) (dropped out) 2 as according to § 2 para 1 person ordered a) violates article 4 para fills to 1 or 3 drugs or get off, b) contrary to Article 4a, paragraph 1 acquires a drug , medicinal products not in the prescribed manner is c) contrary to article 5, paragraph 1, d) kept drugs not in the prescribed manner contrary to section 5, paragraph 3, sentence 1, e) contrary to section 5, paragraph 3, sentence 2, medicines not marks, f) contrary to § 5 para 3 sentence 3 the competent authority does not or not timely informed g) violates article 6 par. 2 supplies attaches no documents or documents with incorrect or incomplete information , h) contrary to article 7, paragraph 1 or paragraph 2 sentence 1 records not, not properly or not leads, i) records or evidence not according to § 7 para 3 sentence 1 or 2, kept also in conjunction with Section 7a para 2 sentence 3, or j) contrary to article 7, par. 3, sentence 5 or 6, each also in combination with Article 7a, paragraph 2, sentence 3 records or evidence is illegible or makes changes or 3 as a medicinal agent a) contrary to article 7, paragraph 1 , also in connection with article 9, paragraph 1, sentence 2 and paragraph 2 sentence 1 a recording, incorrectly, incompletely or not in the prescribed manner does not, b) contrary to § 7 paragraph 3 sentence 1, also in conjunction with section 9 paragraph 1, sentence 2, kept a record of not or at least five years, c) contrary to article 7, paragraph 3, sentence 5 or 6 , also in conjunction with section 9 paragraph 1, sentence 2, a record is unreadable or makes a change or d) contrary to article 9, paragraph 3 the competent authority does not or not timely informed.

Article 11 transitional provisions (1) medicinal products which have been racked this regulation according to the relevant regulations, packed or marked before the entry into force of this regulation must still until brought to 31 December 1988 in the traffic.
(2) premises and equipment must comply with the provisions of this regulation at the latest on 31 December 1988. The competent authority can allow beyond temporary derogations Furthermore, if there is an important reason.
(3) a person who operates a wholesale trade in medicinal products within the meaning of § 9 para 1 for entry into force of this regulation, is the official recognition in the sense of § 9 provisionally as granted. The preliminary official recognition goes out, 1 if not until June 30, 1988 issuing a final official recognition is requested, 2. in the event of timely submission of entry the nonrepudiation of the decision on the application.
(4) pharmaceutical products, which transferred regulation according to the regulations of this, packed or marked in the area referred to in article 3 of the Unification Treaty may be placed there until December 31, 1991 on the market.
(5) operation rooms and facilities in the area referred to in article 3 of the Unification Treaty must comply with the provisions of this regulation at the latest on 31 December 1992. The competent authority can allow beyond temporary derogations Furthermore, if there is an important reason.
(6) a person who operates a wholesale trade in medicinal products within the meaning of § 9 para 1 to be of accession in the area referred to in article 3 of the Unification Treaty, is the official recognition in the sense of § 9 provisionally as granted. The preliminary official recognition is void if not applied until 30 June 1991 providing a final official recognition and, in the case of timely submission, with the nonrepudiation of the decision on the application for admission.

§ 12 (dropped out) § 13 entry into force this regulation into force on January 1, 1988.

Concluding formula of the Federal Minister for youth, family, women and health