Regulation On The Wholesale Trade And The Drug Agency

Original Language Title: Verordnung über den Großhandel und die Arzneimittelvermittlung

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$20 per month, or Get a Day Pass for only USD$4.99.

Ordinance on wholesale and drug delivery (Pharmaceutical Trade Regulation-AM-HandelsV)

Non-official 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. I p. 3108), "

:Last modified by Art. 2 G v. 7.8.2013 I 3108

For details, see the Notes

Footnote

(+ + + text evidence from: 1.1.1988 + + +)
menu (+ + + changes due to change). United Vtr. § 11 + + +)
Heading: IdF d. Art. 7 No. 1 G v. 19.10.2012 I 2192 mWv 2.1.2013 Non-Official Table of Contents

Input Formula

On Reason
-
of § 12 para. 1 No. 1 and 2 of the Pharmaceutical Act of 24. August 1976 (BGBl. 2445, 2448), paragraph 1 of which is replaced by Article 1 of the Law of 16 June 1991. August 1986 (BGBl. 1296), will be in agreement with the Federal Ministers for Economic Affairs, Labour and Social Affairs and for Food, Agriculture and Forestry, and
-
of § 54 para. 1 to 2a of the Medicines Act, its title as well as the first sentence of paragraph 1 and paragraph 2 no. 1 by Article 1 of the above-mentioned Law of 16. August 1986 and paragraph 1, second sentence, as referred to in Article 1 of the Third Jurisdiction Adjustment Regulation of 26 August 1986. November 1986 (BGBl. 2089), and paragraph 2a thereof, by Article 1 of the Law of 24. February 1983 (BGBl. 169), is hereby agreed with the approval of the Federal Council in agreement with the Federal Ministers for Economic Affairs, the Environment, Nature Conservation and Nuclear Safety, and for Food, Agriculture and Forestry
name="BJNR023700987BJNE000203360 " />Non-Official Table of Contents

§ 1 Scope

This Regulation applies to establishments and facilities where they are wholesale Medicinal products are not subject to the conditions laid down in Article 1 (2) of the pharmaceutical and active substance manufacturing regulation of 3 June 2008. November 2006 (BGBl. 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. Non-official table of contents

§ 1a Quality Assurance System

Holes and facilities must be subject to the EU guidelines for good sales practice of In the case of medicinal products, and for this purpose, a functioning quality assurance system shall operate in accordance with the nature and extent of the activities carried out, which shall include the active participation of the management. 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 person responsible pursuant to § 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. Non-official table of contents

§ 2 staff

(1) Anyone who operates a wholesale medicine has at least one person for each establishment. , which is responsible for the proper operation, in particular for compliance with the provisions of § § 1a, 4 to 7c of this Regulation.(2) Personnel shall 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. Non-official table of contents

§ 3 Nature, size and setup of the operating rooms

(1) The operating rooms must be in accordance with type, size, number, location, State and establishment ensure proper operation of the wholesale trade in medicinal products.(2) The operating rooms must have suitable climatic conditions and must be protected against the access of unauthorised persons by appropriate measures.(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: style="font-weight:normal; font-style:normal; text-decoration:none; ">
1.
the frequency of actions,
2.
the cleaning process to be performed and the devices and aids to be used,
3.
the Oversight of persons.
Unofficial table of contents

§ 4 Refilling, packaging and labelling of medicinal products

(1) Only those Medicinal products must be refilled or packaged for the purpose of delivery, the quality of which is found to be of the necessary quality.(2) Due to the spatial or temporal separation of the individual operations or other appropriate technical or organisational measures, provision should be made for a mutual adverse effect on the medicinal products and for confusion. should be avoided.(3) Medicinal products may only be filled or packaged in containers which ensure 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. Non-official table of contents

§ 4a Reference to and withdrawal of medicinal products

(1) Medicinal products may only be authorized to supply medicinal products. Holdings are purchased.(2) The deliveries shall be checked at each acceptance as to whether
1.
the containers are undamaged
2.
The delivery is the same as the order,
3.
the supplier is given the issuing authority and the date of issue have confirmed that it has the necessary permission to do so,
4.
the drug mediator, as far as he is entitled to , and
5.
for certain medicinal products according to § 10 (1c) of the German Medicines Act (Medicines Act)
() In so far as the medicinal products are obtained from an establishment with a permit pursuant to Section 52a of the Medicines Act or via a mediator, the medicinal product concerned shall be subject to the following conditions: To convince recipients 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 in accordance with the Pharmacies Act or which otherwise have the right to submit to the consumer. Non-official table of contents

§ 5 Storage

(1) Medicinal products are to be stored in such a way that their quality is not adversely affected and confusion is should be avoided. The storage temperature required for certain medicinal products shall be ensured by means of refrigeration equipment or other measures. Storage instructions must be observed.(2) The storage containers must be designed in such a way that the quality of the content 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-made medicinal products are stored.(3) Counterfeit medicinal products identified in the distribution network and other non-marketable medicinal products shall be kept separately from marketable medicinal products and secured until the decision on further action is taken to ensure that: Avoid confusion and prevent unauthorized access. They must be clearly labelled as not intended for sale. The competent authority and the marketing authorisation holder shall be immediately informed of the occurrence of counterfeit medicines.(4) Medicinal products which are not marketable are to be destroyed or, to the extent that a return to the supplier is provided for, to be returned. Non-official table of contents

§ 6 extradition

(1) Unless otherwise permitted by law, deliveries of medicines may only be shall be made to establishments and establishments which have a permit pursuant to § 13 or Article 52a of the Medicinal Products Act or a permit referred to in Article 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 authorised, in accordance with the applicable laws, regulations and administrative provisions of their State, to obtain medicinal products for wholesale or for supply to the public.(2) The supplies shall be accompanied by sufficient documentation, in particular the date of delivery, the name and quantity of the medicinal product, and the name and address of the supplier and the consignee. 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 add the batch designation also applies to
1.
when delivering Medicinal products to pharmaceutical companies, hospital pharmacies and pharmacies providing hospital care for the purposes of supplying hospitals,
2.
in the case of Delivery of blood preparations, sera from human blood and preparations from other substances of human origin, as well as genetically engineered blood components, which replace missing blood components, including when delivered to plants and Equipment for delivery to the final consumer,
3.
for medicinal products intended for use in animals, and
4.
in the case of drug delivery, which must bear security features within the meaning of Section 10 (1c) of the Medicines Act.
(3) During the transport of the medicinal products, to ensure that there is no unauthorised access to the medicinal products and that the quality of the medicinal products is not adversely affected, until such time as the recipient is responsible. Non-official table of contents

§ 7 Documentation

(1) Each reference and supply of medicinal products are records in the form of To carry out purchasing/sales invoices, in computerised form or in any other form, which contain the information in accordance with section 6 (2).(1a) (2) records shall also be kept 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; information shall be provided on the date and 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 the person who has been designated by the person responsible for the name.(3) The records referred to in paragraphs 1 and 2 and the evidence in accordance with Section 47 (1b) of the Medicines Act 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 shall 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 the case of record keeping on data carriers, it is necessary in particular to ensure that the data are available for the duration of the retention period and can be made legible within a reasonable period of time. Non-official table of contents

§ 7a Revocation plan, revocation of medicinal products

(1) Anyone who operates a wholesale medicine must have a recall plan. , which shall ensure the implementation of any recall of a medicinal product, which shall be carried out in accordance with the information provided by the competent authorities or by the pharmaceutical entreprenter.(2) The recall plan and the organisational procedures necessary for this must be laid down in writing. Records must be kept on the implementation of recalls. Section 7 (3) shall apply accordingly. Unofficial Table Of Contents

§ 7b Withdrawal of Medicinal Products

(1) The operator of a wholesaling of medicinal products shall take medicinal products supplied by the operator The recipients shall be stored separately from the stocks intended for delivery until a decision is taken on their further use.(2) If the returned medicinal products are not marketable medicinal products, or if they do not provide information on the ability to transport, they shall be deemed to be non-marketable, and shall be deemed to be non-marketable, and of destruction. To the extent that a return has been ordered or agreed with the pharmaceutical contractor, they shall be returned after appropriate identification.(3) Where the medicinal products withdrawn are medicinal products which are capable of being returned, they shall be subject to an examination before the decision on their further use. The medicinal products may only be re-included in the stocks intended for sale if
1.
Return by business documents such as delivery notes or invoices proves that he has obtained them from the wholesaler of the pharmaceutical industry,
2.
the returning in writing Confirms that they have been properly stored and handled since the delivery, in particular have not left their area of responsibility,
3.
Original containers and in the proper state,
4.
they have a reasonable shelf life,
5.
no information from the pharmaceutical entreprender or the competent authority on the lack of transport capability is available,
6.
No other clues for a lack of traffic capability. 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 must be carried out by specially trained personnel. The test instruction and the organisational procedures must be specified in writing. Non-official table of contents

§ 7c Self-inspection

(1) In order to ensure compliance with the provisions of this Regulation, regular Self-inspections are carried out. Records must be kept and kept by means of the self-inspections and subsequent measures taken.(2) The person ordered pursuant to section 2 (1) shall ensure that medicinal products are only obtained from suppliers authorised to trade in medicinal products. Non-official table of contents

§ 8 Service readiness in times of crisis

The competent authority may be ready for service. Order pharmaceutical wholesalers if and as long as the necessary supply of pharmacies and veterinary medicinal products with medicinal products would otherwise be seriously compromised. The arrangement is temporary; it can be extended. Non-official table of contents

§ 9 Requirements for drug intermediaries

(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 shall be kept.(2) The pharmaceutical agent has to be satisfied that the medicinal products subject to authorisation or authorisation to which it is acting shall be authorised to be placed on the market within the scope of the law or approval following the Regulation (EC) No 726/2004.(3) The competent authority and the respective marketing authorisation holder shall be immediately informed of any suspicion of a falsification of medicinal products. Non-official table of contents

§ 10 Administrative Offences

is an administrative offence within the meaning of Section 97 (2) (31) of the Medicines Act, who intentionally or negligently
1.
as operator of a wholesaling of medicinal products
a)
contrary to § 2 para. 1 a responsible person not ordered or
b)
(omitted)
2.
as the person ordered in accordance with § 2 para. 1 style="font-weight:normal; font-style:normal; text-decoration:none; ">
a)
counter to § 4 para. 1 or 3 medicines refilled or unpacked,
b)
contrary to § 4a, paragraph 1, a medicine acquires a medicine,
c)
contrary to § 5 para. 1 medicinal product not in the
d)
contrary to § 5 para. 3 sentence 1 of medicinal products not stored in the prescribed manner,
e)
contrary to § 5 para. 3 sentence 2 medicinal products not marked,
f)
contrary to § 5 para. 3 sentence 3 the competent
g)
contrary to § 6 (2), no documents or documents with an uncorrect or not complete information are not available. Disclosures,
h)
contrary to § 7 (1) or (2) sentence 1, records do not, either correctly or incompletely,
i)
Recordings or proof not in accordance with § 7 (3) sentence 1 or 2, also in conjunction with § 7a para. 2 sentence 3, preserved or
j)
contrary to § 7 para. 3 sentence 5 or 6, also in connection with § 7a para. 2 sentence 3 notes or evidence makes illegible or makes changes or
3.
as a drug mediator
a)
contrary to § 7, paragraph 1, also in conjunction with § 9 paragraph 1 sentence 2, or paragraph 2 sentence 1, a record not, not correct, not complete or not in the prescribed manner ,
b)
contrary to § 7, paragraph 3, sentence 1, also in conjunction with Section 9, paragraph 1, sentence 2, a record not or not kept for at least five years,
c)
contrary to § 7, paragraph 3, sentence 5 or 6, also in conjunction with § 9 paragraph 1 sentence 2, makes a recording unreadable or makes a change or
d)
contrary to § 9 paragraph 3, the competent authority is not informed or not informed in due time.
unofficial table of contents

§ 11 transitional provisions

(1) medicinal products that do not comply with the provisions of this Regulation before the entry into force of this Regulation, have been unpacked or marked up to 31. It will be placed on the market in December 1988.(2) The operating rooms and facilities must be at the latest by 31. December 1988 shall be in accordance with the provisions of this Regulation. The competent authority may, in addition, allow temporary exemptions where there is an important reason.(3) If, upon 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 be deemed to be granted on a provisional basis within the meaning of § 9. The provisional official recognition is issued,
1.
if not up to 30.
2)
2.
in the event of a timely application, with the entry of the unquestionability of the decision, the application.
(4) 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 still be allowed to take place there until 31 December 2008. It will be placed on the market in December 1991.(5) premises and facilities in the area referred to in Article 3 of the agreement must be made at the latest by 31 December 2002. This Regulation shall comply with the provisions of this Regulation. 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 within the meaning of Article 9 (1) is operated, the official recognition shall be deemed to be granted on a provisional basis within the meaning of § 9. The provisional official recognition shall be issued, if not until 30. The Court held that a final official recognition was requested in June 1991 and, in the case of a timely application, the decision on the application to be indisputable. unofficial table of contents

§ 12 (omitted)

unofficial Table of Contents

§ 13 Entry into force

This Regulation shall enter into force on 1 July. January 1988. Non-official table of contents

Final formula

The Federal Minister for Youth, Family, Women and Health