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Notice Of Sale Of Otc Medicines Outside Pharmacies

Original Language Title: Bekendtgørelse om forhandling af håndkøbslægemidler uden for apotek

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Table of Contents

Appendix 1

Appendix 2

Appendix 3

Annuntation of the negotiation of small-pharmacy hand-over pharmacies

In accordance with section 40 (1). 1 and 3, section 44 (3). 1, Article 84 (4). 1, and Section 104 (3). 3, in the case of medicinal products, cf. law no. 1180 of 12. In December 2005, as amended by law no. 1557 of 20. December 2006 and Law No 534 of 17. June 2008 shall be adopted according to the authority :

Conventing of the Bekendom Decision

§ 1. This notice shall apply to the retailer of medicinal products exempted from apothecary reservations following a specific health professional judgment pursuant to Article 60 (60) of the medicinal product. 2. The medicinal products are included in the medicinal product management register of approved medicinal products during the extradition group HF, HX or HX18.

Stk.2. The announcement does not include the negotiation of medicinal products at the pharmacy, apothecary, apothecary sale and the sale of the purchase of the trade.

Paragraph 3. The compilation does not include the retail distribution of gas for medical use, regulated in the notice of gas for medical use.

Retailer permission

§ 2. Treatment of medicinal products referred to in section 1 (1). 1 may only be carried out with the consent of the Medicinal Products for the medicinal purposes, cf. Article 39, paragraph 39 of the medicinal product. 1.

§ 3. In order to obtain the medicinal product of the medicinal product, according to Article 39 (3) of the medicinal product, 1, for the negotiation of medicinal products referred to in section 1 (1). 1. (Retailer) the applicant must have staff, premises, technical equipment and control facilities that enable compliance with the provisions of this notice.

§ 4. Applications for retailer authorisation shall be submitted in a special form to be obtained from the network of the Medicinal Management Board or by contacting the Administrative Board.

§ 5. The governing board shall first issue the distributor by the Management Board, after verifying that the applicant meets the requirements of section 3.

§ 6. A distributor authorisation shall provide access to the purchase of medicinal products referred to in section 1 (1). 1, from wholesalers, manufactures or importer, who are authorized in accordance with section 39 (5). 1, in the pharmaceutical bill, and store and negotiate the medicinal products for the users, cf. however, paragraph 1 2.

Paragraph 2. A distributor licence, which alone covers medicinal products for the treatment of genes in the case of back-treatment, does not grant access to the purchase, store and negotiate for other medicinal products referred to in section 1 (2). 1.

Paragraph 3. A Reseller Permit does not allow access to

1) changing the packaging of a medicinal product,

2) breach the finished packaging in which a medicinal product is delivered from wholesaler, manufacturing or importer, or

3) establish or engrosnegotiate medicinal products.

§ 7. The holder of a distributor ' s authorization shall keep the authorization at the site covered by the authorization and shall ensure that the authorisation is available to the Medicinal Management Board for any inspection carried out in accordance with the authorization ; to section 44 (3). 1, in the law on medicinal products.

Documentation

§ 8. The negotiator shall have the following information on medicinal products purchased for resale :

1) Delivery date.

2) Pharmaceuticals, pharmaceutical form and strength.

3) Number of packages.

4) Paking Size.

5) Supplier's name and address.

Paragraph 2. The negotiator shall ensure that documentation is available for the information referred to in paragraph 1. 1, in the form of purchase invoices, Edb Data, or other documentation.

Paragraph 3. The information referred to in paragraph 1. 1, must be kept at the distributor ' s address for at least five years. In the light of this information, the distributor must be able to carry out a withdrawal of a medicinal product.

Organization and personnel

§ 9. The negotiator must have a staff who is familiar with the content of this notice. A person who is responsible for the establishment of a company shall be designated in accordance with the provisions of this notice.

Storage and sale

§ 10. The negotiator must ensure that storerooms are sufficiently large to enable the maintenance of good order and the principle of principle first only in the first place.

Paragraph 2. Destruction of medicinal products must be kept separate from other goods.

§ 11. The negotiator must ensure that medicinal products are suitably stored and suitably stored.

Paragraph 2. The medicinal products must be kept at the temperature indicated on the packaging. If a storage temperature is not specified, the storage must be at least 15 ºC and no more than 25 ºC.

§ 12. The negotiator must ensure that medicinal products

1) are not sold to children under 15 years, cf. however, paragraph 1 3,

2) is not in self-selection and kept unavailable to the business customers (behind disk, in locked cabinet e.l), and that :

3) medicinal products are only sold at the express request of the customer.

Paragraph 2. A package shall be sold at a maximum of the maximum. customer per the day of each medicinal product recorded in the Medicines Board of Medicinal Products of approved medicinal products during the extradition group HX or HX18. However, if several medicinal products containing the same active substance are available for the extradition group HX or HX18, one package shall be sold at a maximum of each other. customer per the days of medicinal products containing the same active substance.

Paragraph 3. Medicinal products in the extradition group HX18 shall only be sold to persons in 18 years or more.

§ 13. As a minimum, the handler must keep the basic range set out in Appendix 1. However, this does not apply if the distributor is authorised alone to negotiate medicinal products for the treatment of genes in the case of back-rehab.

§ 14. The negotiator shall forward commercials over a medicinal product to the supplier.

Paragraph 2. The negotiator shall ensure that medicinal products returned from a customer or whose durability time has been exceeded or which cannot be accepted in the case of applicable quality requirements, are not provided to users. Such medicinal products must be returned to the manufacturer or the supplier or be destroyed in a responsible manner.

Reporting of circulation and so on of medicinal products

§ 15. The negotiator must be months before the 10th. in the following month, information on the turnover and so forth of medicinal products for the Medicinal Board of Medicinal Products. This also applies even if the reseller has not had a turnover in the month concerned.

Paragraph 2. A negotiator with a licence to negotiate all the medicinal products referred to in paragraph 1 (1). The first subparagraph shall be submitted for the first subparagraph. 1 the information referred to in the machine-readable condition as described in Annex 2 or electronic, as described in Annex 3.

Paragraph 3. A distributor whose sole authorization to negotiate medicinal products for the treatment of genes in return is subject to the submission of the products referred to in paragraph 1 shall be submitted. 1 mentioned information in electronic form, as described in Annex 3.

Special Obligation to Company Assignment

§ 16. The person who acquires an undertaking subject to a distributor's authorisation shall notify the owner of the Medicinal Products Agency and shall at the same time indicate whether or not it wishes to maintain the authorisation. If so, the new owner must sign a special declaration that he or she is aware of and intends to comply with the rules in this notice. The declaration may be obtained in the network of the Medicinal Management Board or by contacting the Management Board.

Inspection

§ 17. After all inspection at the retailer in accordance with section 44 (4), 1, in the law on medicinal products, the Medical Board shall prepare a report on the compliance of this notice. The inspection report shall be sent to the interested party concerned by the inspection visit.

Paragraph 2. Inspections reports shall be kept at the retailer's address.

Pensation

§ 18. In specific cases, the governing board may dispense with the rules in this notice.

Punishment and entry into force

§ 19. The penalty will be penalised by the penalty that violates section 6 (6). 3, SECTIONS 7-12, § 13, 1. pkt., sections 14-15, § 16, 1. and 2. pkt., or section 17 (3). 2.

Paragraph 2. Companies can be imposed on companies, etc. (legal persons) punishable by the rules of the penal code 5. Chapter.

20. The announcement will enter into force on the seventh. March, 2011.

Paragraph 2. Publication no. 993 of 5. In October 2006, on the negotiation of small-pharmacy hand-off pharmacies are hereby repealed.

Medical Board, the 9th. February, 2011

Jytte Lyngvig

/ Anne-Marie Vangsted


Appendix 1

Base sortiment, cf. § 13.

At least one medicinal product must be negotiated within each of the following product groups :
Primary Scope
Medium-
form
Active content and strength.
Where an active substance or strength is not specified, there are no specific requirements for the substance or strength. Where more than one substance is specified, the medicinal product must contain all substances.
Disinfectant (neck of throat)
Suction tablets
Gener on back-getting used
Gum
Nicotine-2 mg
Gener on back-getting used
Gum
Nicotine-4 mg
Mavesyreneutralizing
Chewing tablets
Slimlading (bravery)
Brusettes or oral fluids
Painkillers
Dropped
Acetylsalicylic acid-500 mg
(It may be a combination sprout-
Preparation or pure acetylsalicylic acid.)
Painkillers
Dropped
Ibuprofen-200 mg
Painkillers
Dropped
Paracetamol-500 mg
Transportation sickness
Dropped

Appendix 2

Description of the information which months shall be submitted to the Medicinal Management Board in a machinanreadable form, cf. § 15 , paragraph 1. 2

1. General notes

1.1. The sale of medicinal products exempted from apothecary reservations shall be reported by the negotiator once a month. Notification may be left to the retailer, for example, to a group, the reseller is part of, or an accounting firm.

The person who makes the reporting to the Medicinal Board shall be referred to in the following notification. In order to identify the alert and sales point, the numbers from the Central Enterprise Registry (CVRP and P numbers) are used.

Each sales point shall be reported for each item number the total number of packages sold and the total turnover.

2. Basic data information

2.1. Unless a special agreement has been reached with the medical board for the notification of a second way, the report shall be carried out in one of two ways :

-WHAT? Via upload of a file to the Medicines Management FTP server. Address, user ID and password for the FTP server are reported in connection with the approval of the sales site. The file must be a text file in ASCII format (each line of the file ends with CR and LF, ASCII 13 and ASCII 10).

-WHAT? The entry on the alert page www.lmsdetail.dk. (see Appendix 3).

2.2. The text file is named as follows :

a. In the report directly from a point of sale :

NNNNNNNNN.MMX

where

NNNNNNNNNNN is the point number (10 digits) of the sales character (10 digits)

MM is the month number (2 digits) and

X is always given by the letter "A".

b. By reporting for one or more sales points through, for example, group or audit company :

AANNNNNNN.MMX

where

AA is the "CV" letter code.

NNNNNNNNN is the report (CVR number of the notification) number (8 digits),

MM is the month number (2 digits) and

X is always specified with the letter "A"

2.4. The first line of the file (headerline) must have the following fixed content :

No!
Type
From
To
Lgd.
Description of content
F1
A
1
6
6
Interface identification
F2
A
7
21
15
Edge Vendor Identification
F3
A
22
26
5
The authentication number of the Edb-system
F4
N
27
32
6
Print date (YYMMDD)
F5
A
33
42
10
Resume's CVR number
F6
N
43
52
10
P-number of sales steep
F7
N
53
56
4
Compose year / month, ÅÅMM
F8
N
57
61
5
Month total number of records (00001-99999)
F9
N
62
66
5
Number of records on file (00001-99999)

The fields F1, F2, F3, F3, F5, and F6 in the header line are completed according to the following guidelines :

No!
Field Content
Fulfillment
F1
Interface identification
LIBLM1
F2
Edge Vendor Identification
The content is determined by the alert
computer supplier and communicated to the Medicinal Products Agency ;
F3
The authentication number of the Edb-system
The content is determined by the notification supplier of the notification. This field must be used, inter alia, by any possibility corrective action, etc., in connection with the reporting. This field is always required to be completed and must be updated when commissioning new software versions of the alert.
F5
Resume's CVR number
The CVR number is entered with a leading letter tag "resume / CV"
F6
P-number of sales steep
The P number (s) of the Sales character is recorded at the point of entry directly from the point of sale.
In the report of one or more sales points through, for example, group or accounting firm, the field must be blank.

3. Description of information to be reported

3.1. Following the headerline line, the line is followed by the following specified information per. Sold item number per. Sales location. All lines in the file must have the same length, cf. section 3.2 below.

FELT01 Expedition Type
Contains the letter code "LS".
FELT02 Sales of the Sale of Sale
This field is populated with the sales site number for the production unit.
FELT03 Sales year and month
Year (s) and month for sale
FELT04 Item Number
This field is filled in with the product ' s product number, which is shown by the packaging.
FELT05 Quantity sold packages
This field is populated with the month's sale of the item in question.
FELT06 Month's total sales in ears inat VAT
The total sales for the item in question.

3.2. A summary of information to be reported below is provided below. The schema shows the order and length of the fields.

A distinction is made between two types of fields : N, that is numeric fields (digits only), and A, which is alphanumeric fields (text, case-letters, and digits in combination). The size of the field (number of characters) immediately follows the field type (e.g. N10 or A2). The leading zeros are reported in all fields.

For each item number that is sold, all fields must be completed.

Feltnr.
Description
Type /
Lgd.
Position
Value quantities
01
Expedition Type
A2
1-2
Make up with "LS"
02
P-number of sales steep
N10
3-12
10 digits
03
Sales year and month
N4
13-16
ÅYYMM : 0001-9912
04
Item Number
N6
17-22
6 digits
05
Quantity Sold sold
N5
23-27
00001 99999
06
The sale of the month in the ears of the month. VAT
N10
28-37
for example : 0000010025

Appendix 3

Description of the information for months to be submitted to the Medicinal Management Board in electronic form, cf. section 15 , paragraph 1. 2 and 3

General notes

1.1. The sale of medicinal products exempted from apothecary reservations shall be reported by the negotiator once a month. Notification may be left to the retailer, for example, to a group that the reseller is a part of, or an accounting firm.

The person who makes the reporting to the Medicinal Board shall be referred to in the following notification. In order to identify the alert and sales point, the numbers from the Central Enterprise Registry (CVRP and P numbers) are used.

Each sales point shall be reported for each item number the total number of packages sold and the total turnover.

2.1. Notification shall be made on : www.lmsdetail.dk Before the notification can take place, a password must be requested in the Medical Board.

3.1. The information provided for in the following information shall be reported by the Sold item number per. sales point :

1) Sales year and month

2) Item number (the number of the Nordic item number that is specified in the packaging)

3) Number of sales of packages sold (the month ' s sale of the item in question) ;

4) The total sale of the month, including VAT, for that item number.