Regulation on wholesale trade and the mediation of medicinal products (Pharmaceutical Trade Regulation-AM-HandelsV)

Unofficial table of contents

AM-HandelsV

Date of completion: 10.11.1987

Full quote:

" Pharmaceutical trade regulation of 10 November 1987 (BGBl. 2370), as last amended by Article 2 of the Law of 7 August 2013 (BGBl). 3108).

Status:

Last amended by Art. 2 G v. 7.8.2013 I 3108

For more details, please refer to the menu under Notes

Footnote

(+ + + Text evidence from: 1.1.1988 + + +)
(+ + + Changes due to EinigVtr cf. § 11 + + +)
Heading: IdF d. Art. 7 No. 1 G v. 19.10.2012 I 2192 mWv 2.1.2013 Unofficial table of contents

Input formula

Because of

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Article 12 (1) (1) and (2) of the Medicinal Products Act of 24 August 1976 (BGBl). 2445, 2448), paragraph 1 of which is Article 1 of the Law of 16 August 1986 (BGBl I). 1296), will be in agreement with the Federal Ministers for Economic Affairs, Labour and Social Affairs and for Food, Agriculture and Forestry, and

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Article 54 (1) to (2a) of the Medicinal Products Act, the title of which and the first sentence of paragraph 1 and paragraph 2 (1) by Article 1 of the Act of 16 August 1986 referred to above and the second sentence of paragraph 1 of Article 1 of the Third Party Act Regulation of Jurisdiction Adjustment of 26 November 1986 (BGBl. 2089) and paragraph 2a of this Article by Article 1 of the Law of 24 February 1983 (BGBl I). 169), shall be inserted in agreement with the Federal Ministers for Economic Affairs, the Environment, Nature Conservation and Nuclear Safety, and for Food, Agriculture and Forestry

, with the consent of the Federal Council: Unofficial table of contents

§ 1 Scope

This Regulation shall apply to establishments and establishments in so far as they are driving wholesalers with medicinal products, unless, in accordance with Article 1 (2) of the Medicines and Active Products Regulation of 3 November 2006 (BGBl I). 2523), the rules of which shall apply. The Regulation shall also apply to pharmaceutical agents within the meaning of Article 4 (22a) of the Medicines Act, in so far as this Regulation is intended to do so. Unofficial table of contents

§ 1a Quality Assurance System

Establishments and bodies must comply with the EU guidelines for the good distribution practices of medicinal products and, for this purpose, operate a functioning quality assurance system in accordance with the nature and scope of the activities carried out, which shall be the active Participation of the management board. The quality system must, in particular, ensure that medicinal products are only supplied by authorised establishments and facilities and are only supplied to them, the quality of the medicinal products, even during storage and transport, is not , to avoid confusion and to provide a sufficient system of tracing, including the implementation of a recall. The responsible person ordered pursuant to section 2 (1) must in particular ensure that the medicinal products are referred to and extradited in accordance with § § 4a and 6 and that the written procedure descriptions are checked at regular intervals, if necessary, adapted to the state of science and technology and be followed. Unofficial table of contents

§ 2 Staff

(1) Anyone who operates a wholesale medicine shall have at least one person responsible for the proper operation, in particular for compliance with the provisions of Sections 1a, 4 to 7c of this Regulation, for each establishment responsible for the operation of the medicinal product. (2) Personnel must be provided with sufficient professional qualifications and sufficient number to enable compliance with the provisions of this Regulation. It may only be employed in accordance with its training and knowledge, and must be regularly informed of the care provided in the handling of medicinal products. Unofficial table of contents

§ 3 Nature, size and furnishing of the operating rooms

(1) The premises must be in accordance with the type, size, number, position, state and equipment of the wholesale trade in medicinal products. (2) The premises must be in a suitable climatic condition and shall be provided by: (3) The equipment used should be easy to clean and must be kept in place. (4) Operating rooms and their facilities must be cleaned regularly. Where medicinal products are filled, packaged or labelled in the operating rooms, a written hygiene plan shall be drawn up in which, in particular, the following shall be adopted:

1.

the frequency of the measures;

2.

the cleaning procedures to be carried out and the equipment and tools to be used,

3.

the persons responsible for supervision.

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§ 4 Refilling, packaging and labelling of medicinal products

(1) Only such medicinal products may be refilled or packaged for the purpose of delivery of which the required quality is established. (2) By separating the individual operations in space or by time or by other appropriate technical means (3) Medicinal products may only be filled or packaged in containers which ensure that they are not adversely affected by the adverse effects of the medicinal product on the market. that the quality is no longer unavoidably affected. (4) Medicinal products intended for use in humans and not manufactured medicinal products may be placed on the market only if their containers and, where used, the outer envelopes according to Article 10 (1) (1), (2), (4), (8) and (9) of the Drug law in legible writing, in German language and in a permanent way. Medicinal products intended for use in animals which are not ready-to-use medicinal products may be placed on the market only if the containers and, where used, the outer envelopes containing the information provided for in § § 10 and 11 of the Pharmaceutical law is provided. Unofficial table of contents

Section 4a The reference and withdrawal of medicinal products

(1) Medicinal products may only be purchased from holdings authorised to supply medicinal products. (2) The deliveries shall be checked at any time when they are accepted, whether or not:

1.

the containers are undamaged;

2.

the delivery is in accordance with the order,

3.

the supplier has confirmed, indicating the issuing authority and the date of issue, that it has the necessary permission,

4.

the drug mediator, as far as he is used, has made the necessary notification for registration, and

5.

the safety features provided for in certain medicinal products pursuant to Section 10 (1c) of the Medicinal Products Act are evidence of the authenticity of the medicinal product.

(3) Insofar as the medicinal products are obtained from an establishment with a permit pursuant to Section 52a of the Medicines Act or via a drug mediator, the recipient has to be convinced of their compliance with the good sales practice. (4) Medicinal products may be withdrawn from establishments and facilities which have a permit pursuant to Section 52a of the Medicines Act or the pharmacies act or which otherwise have the right to submit to the consumer. Unofficial table of contents

§ 5 Storage

(1) Medicinal products must be stored in such a way that their quality is not adversely affected and any confusion is avoided. The storage temperature required for certain medicinal products shall be ensured by means of refrigeration equipment or other measures. The storage conditions must be such as to ensure that the quality of the contents is not impaired. They must be marked with clear inscriptions, which clearly indicate the content. To the extent that the names are prescribed by law pursuant to Section 10 (6) (1) of the Medicines Act, these are to be used. The content shall be marked by additional information to the extent that this is necessary to avoid confusion. Phrases 2 to 4 shall not apply to storage containers in which properly labelled ready-to-use medicinal products are stored. (3) Counterfeit medicinal products identified in the distribution network and other non-marketable medicinal products are up to to decide on the further procedure separately from marketable medicinal products and secured, in order to avoid confusion and to prevent unauthorised access. They must clearly be labelled as non-sales medicines. The competent authority and the respective marketing authorisation holder shall be informed immediately of the occurrence of counterfeit medicines. (4) Medicinal products which are not marketable are to be destroyed or, where a return to the supplier is concerned, is to be returned. Unofficial table of contents

§ 6 Delivery

(1) Unless otherwise permitted by law, deliveries of medicinal products may only be made to establishments and facilities which are subject to a permit pursuant to § 13 or § 52a of the Medicines Act or a permit pursuant to Article 13 of the German Medicines Act. 40 or a permit referred to in Article 77 of Directive 2001 /83/EC, or a permit referred to in Article 44, or a permit referred to in Article 65 of Directive 2001 /82/EC, or authorised to be submitted to the final consumer. If wholesalers supply medicinal products intended for use in humans, to persons established outside the European Union or any other Contracting State of the Agreement on the European Economic Area, they shall ensure that they are satisfied, the beneficiaries are entitled under the applicable laws, regulations and administrative provisions of their State to obtain medicinal products for wholesale or distribution to the public. (2) The supplies shall be accompanied by sufficient documentation from which: in particular, the date of delivery, the name and quantity of the The medicinal product and the name and address of the supplier and the recipient shall be produced. In the case of delivery to other establishments and facilities which have a permit in accordance with § 52a of the Medicines Act, the batch name of the particular medicinal product must also be indicated. In addition, stating the issuing authority and the date of issue, it must be confirmed that the supplier has a permit in accordance with § 52a of the Medicines Act. The obligation to provide additional details of the batch designation shall also apply:

1.

in the supply of medicinal products to pharmaceutical companies, hospital pharmacies and pharmacies providing hospital care for the purpose of supplying hospitals,

2.

in the case of delivery of blood preparations, sera from human blood and preparations of other substances of human origin and of genetically engineered blood components which replace missing blood components, including in the case of delivery to establishments and facilities for delivery to the final consumer,

3.

in the case of medicinal products intended for use in animals, and

4.

in the case of the supply of medicinal products, which have to bear security features within the meaning of Article 10 (1c) of the Medicines Act.

(3) During the transport of the medicinal products, the recipient must be responsible for ensuring that there is no unauthorised access to the medicinal products and that the quality of the medicinal products is not impaired until it is transferred. Unofficial table of contents

§ 7 Documentation

(1) In respect of each and every reference and supply of medicinal products, records shall be kept in the form of purchasing/sales invoices, in computerised form or in any other form, containing the information provided for in Article 6 (2). (1a) (omitted) (2) Records shall also be carried out on the refilling and packaging of medicinal products and on the withdrawal, return or destruction of medicinal products which may not be placed on the market, with information on the date on which the product is to be taken into account. as well as on the nature and quantity of the medicinal products. The records shall be provided by the person appointed pursuant to section 2 (1) or by a person appointed by it. (3) The records referred to in paragraphs 1 and 2 as well as the evidence in accordance with Section 47 (1b) of the Medicines Act shall be shall be kept for at least five years after the last registration. In the case of blood preparations, sera from human blood and preparations of other substances of human origin and of genetically engineered blood components which replace the missing blood components, the records referred to in paragraph 1 shall be at least for thirty years or to store or store it. They are to be destroyed or deleted if the storage or storage is no longer required. If the records are kept or stored for more than 30 years, they are to be anonymized. The original content of an entry must not be made illegible either by means of piercing or by any other means. No changes may be made which do not indicate whether they have been made at the time of the original registration or only later. (4) In order to keep records on data carriers in particular, it must be ensured that: that the data are available during the period of retention and can be made legible within a reasonable time. Unofficial table of contents

Section 7a Revocation plan, withdrawal of medicinal products

(1) Anyone who operates a wholesale medicine must have a recall plan which ensures the implementation of each recall of a medicinal product which is carried out in accordance with the information of the competent authorities or of the pharmaceutical entrepre. (2) The The revocation plan and the necessary organisational procedures must be in writing. Records must be kept on the implementation of recalls. Section 7 (3) shall apply accordingly. Unofficial table of contents

Section 7b Withdrawal of medicinal products

(1) If the operator of a wholesale medicinal product returns medicinal products supplied by the recipient, such medicinal products shall be stored separately from the stocks intended for release until a decision on their further use is made. (2) the medicinal products withdrawn, in accordance with the information provided by the returning medicinal product, or if it does not provide information on the ability to transport them, they shall be declared non-marketable, shall be removed and the destruction . To the extent that a return has been ordered or agreed with the pharmaceutical entrepre, they shall be returned after appropriate identification. (3) If the returned medicinal products are to be returned, according to the returning agent, marketable medicinal products, they shall be subject to an examination before the decision on their further use. Medicinal products may only be re-added to the stocks intended for sale if:

1.

the return shall be made by business records such as delivery notes or invoices, that he has obtained them from the wholesale trade of medicinal products;

2.

the returning person confirms in writing that they have been properly stored and handled since the delivery, and in particular have not left their area of responsibility,

3.

they are in the original containers and in the proper condition,

4.

they have a justifiable shelf life,

5.

no information is available from the marketing authorisation holder or from the competent authority on the lack of transport capacity,

6.

there are no other indications of a lack of transport capacity. The nature of the medicinal product, the necessary storage conditions and the time period elapsed since the delivery has been taken into account. This applies in particular to medicinal products with special requirements for storage conditions.

(4) The examination and decision referred to in paragraph 3 shall be carried out by specially trained staff. The test instruction and the organisational procedures must be specified in writing. Unofficial table of contents

Section 7c Self-inspection

(1) In order to ensure compliance with the provisions of this Regulation, self-inspections must be carried out on a regular basis. Records must be kept and kept on the self-inspections and subsequent measures. (2) The person ordered pursuant to § 2 (1) (1) has to be made sure that medicinal products are only obtained from suppliers who are responsible for the treatment of the products. Trade in medicinal products is authorised. Unofficial table of contents

§ 8 Service readiness in times of crisis

The competent authority may order the readiness of the wholesalers of medicinal products if and as long as the necessary supply of medicinal products to pharmacies and veterinary medicinal products would otherwise be seriously compromised. The arrangement is temporary; it can be extended. Unofficial table of contents

§ 9 Requirements for pharmaceutical agents

(1) § § 1a and 7a shall apply accordingly. The provisions of Article 7 (1), (3) and (4) shall apply in accordance with the proviso that the records relating to the transactions carried out must be kept. (2) The mediator has to be convinced that the authorisation or authorisation must be Medicinal products with which they are acting have a marketing authorisation within the scope of the law or authorisation provided for in Regulation (EC) No 726/2004. (3) The competent authorities responsible for the marketing of medicinal products shall be the competent authorities of the Member States. to inform the authority and the respective marketing authorisation holder immediately. Unofficial table of contents

§ 10 Administrative Offences

Contrary to the provisions of Section 97 (2) (31) of the Medicinal Products Act, who intentionally or negligently acts

1.

as the operator of a wholesale medicine

a)

contrary to § 2 para. 1, a responsible person shall not be appointed or

b)

(dropped)

2.

as a person ordered pursuant to section 2 (1)

a)

, in breach of § 4 para. 1 or 3 medicinal products or packaging,

b)

Article 4a, paragraph 1, acquires a medicinal product,

c)

Contrary to Section 5 (1), medicinal products are not stored in the prescribed manner,

d)

the medicinal product is not kept in the prescribed manner, contrary to Article 5 (3), sentence 1,

e)

Contrary to Section 5 (3), sentence 2 of the medicinal product,

f)

the competent authority is not informed or not informed in due time, contrary to Section 5 (3) sentence 3,

g)

Contrary to Article 6 (2), no documents or documents with information which are not correct or not complete are included in the deliveries,

h)

, contrary to § 7 (1) or (2) sentence 1, records are not kept, not correct or not complete,

i)

keep records or proof not in accordance with § 7 (3) sentence 1 or 2, also in conjunction with § 7a (2) sentence 3, or

j)

Contrary to § 7 (3) sentence 5 or 6, in connection with § 7a (2) sentence 3, records or evidence makes an illegible or make changes, or

3.

as a mediator

a)

Contrary to § 7 (1), even in conjunction with Section 9 (1) sentence 2, or the first sentence of paragraph 2, a record does not result in, not correct, complete or not in the prescribed manner,

b)

contrary to the first sentence of Article 7 (3), including in conjunction with the second sentence of Article 9 (1), a record shall not be kept for at least five years, or

c)

, contrary to § 7 (3) sentence 5 or 6, also in conjunction with Section 9 (1) sentence 2, makes a recording illegible or makes a change, or

d)

Contrary to § 9 (3), the competent authority is not informed or informed in good time.

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Section 11 Transitional provisions

Medicinal products which have not been filled, packaged or labelled in accordance with this Regulation before the entry into force of this Regulation may still be placed on the market until 31 December 1988. (2) Operating spaces and institutions shall comply with the provisions of this Regulation no later than 31 December 1988. The competent authority may, in addition, allow temporary exemptions if there is an important reason. (3) If, on the entry into force of this Regulation, a wholesale trade in medicinal products within the meaning of Article 9 (1) is operated, the official recognition shall apply. For the purposes of Section 9, provisional as granted. The provisional official recognition shall be issued,

1.

if the grant of a definitive official recognition is not requested by 30 June 1988,

2.

in the case of a timely application, the decision on the application shall be indisputable.

Medicinal products which are not filled, packaged or labelled in accordance with the provisions of this Regulation in the area referred to in Article 3 of the Unification Treaty shall be placed on the market until 31 December 1991 (5) premises and facilities in the area referred to in Article 3 of the Agreement must comply with the provisions of this Regulation at the latest by 31 December 1992. The competent authority may, in addition, allow temporary exemptions where there is an important reason. (6) If, in the event of an effective entry into the territory of the territory referred to in Article 3 of the Agreement, a wholesale trade in medicinal products is provided for in the territory of the § 9 (1), the official recognition within the meaning of § 9 shall be deemed to be granted on a provisional basis. The provisional official recognition shall be issued if the grant of a definitive official recognition is not requested by 30 June 1991 and, in the case of a timely application, with the entry into force of the decision on the application of the decision on the Application. Unofficial table of contents

§ 12 (omitted)

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Section 13 Entry into force

This Regulation shall enter into force on 1 January 1988. Unofficial table of contents

Final formula

The Federal Minister for Youth, Family, Women and Health