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Ordinance Amending The Ordinance On Pharmacists ' And Pharmacy Chains Reporting

Original Language Title: Bekendtgørelse om ændring af bekendtgørelse om apotekeres og apotekerkæders aflæggelse af regnskab

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Table of Contents

Appendix 1

Publication of the amendment of the announcement of the closure of accounts and pharmacies of the apothecary shall be made

§ 1

Notice no. 266 of 21. March 2007, apothecary and apothecary chains shall be replaced by the following amendments :

1. I § 17 pasted after 1. pkt . : " The statement of assurance shall be replaced by the text of the certificate of assurance for the pharmacies and pharmacies of the pharmacies and marketing activities. ` ;

2. I § 19 pasted after Act one. : ' The statement of assurance shall be replaced by the ' Statement of Assurance ' s Statement of Assurance relating to the cost substantiated discounts and marketing activities of the pharmacies of the apothecary. `

3. I § 24 pasted after Act one. : ' The statement of assurance shall be replaced by the ' Statement of Assurance ' s Statement of Assurance relating to the cost substantiated discounts and marketing activities of the pharmacies of the apothecary. `

4. I § 26 pasted after Act one. : ' The statement of assurance shall be replaced by the ' Statement of Assurance ' s Statement of Assurance relating to the cost substantiated discounts and marketing activities of the pharmacies of the apothecary. `

5. Appendix 1 the text of Annex 1 shall be replaced by this notice.

§ 2

The announcement shall enter into force on 16. March 2008.

The Ministry of Health and Prevention, the 12th. March 2008 Jakob Axel Nielsen / Paul Schüder

Appendix 1

Template for the preparation of the Statement of Assurance in pharmacies and apothecary chains ' cost substantiated rapests and marketing activities

Declaration by an independent auditor
For the medical board.
Introduction
After agreement, we have completed the work actions that are listed below for the apothecary. cost substantiated discounts and marketing activities, cf. sections § 17 and 19 < sections § 24 and 26 > in Bekendtstatement no. 266 of 21. March 2007, apothecary and apothecary chains shall be held by accounts. Our declaration was made entirely for the apothecary. and the medicinal form of the medicinal unit for the purpose referred to in this declaration.
The objective of the agreed work actions is that as auditors we carry out audit-like work actions concerning the pharmacies, cost-founded discounts and marketing activities required under the Ministry of Health and Prevention Ministry for the revision of the 25. -February 2008. We declare on the outcome of the audit-like work actions carried out below, under the "Actual Results" section.
The following work actions have been completed in accordance with the Danish audit standard of agreed work actions. The following work actions are neither audit nor review in accordance with Danish auditing standards in this respect, and we are alone on the actual results of the actions carried out, and thus do not express a conclusion. whether the pharmacy is a safety issue ; they have received cost-substantiated discounts and amounts relating to marketing activities within the applicable rules on this subject.
If we had carried out further work actions, revised or carried out review in accordance with Danish auditing standards, other circumstances may have been found and reported, and the declaration alone relates to the conditions which are listed below, it may not be extended to the pharmacies of the apothecary. accounts as a whole.
Completed Actions
Our work has been carried out in accordance with the Danish auditing standard of agreed work actions.
Thus, our completed work actions can be summed up as follows :
For cost-founded discounts :
1)
We've got a sample of 10%. -However, at least 5 of them. and the most 25 of them. -checked for the pharmacies, keep records, in the form of invoices and credits, concerning cost substantiated discounts as specified in section 33 < section 37 (3). 2 > in the advertising notice.
2)
We have checked that the sum of the amounts documented, cf. § 33 < ~ 37 (3)) 2 > in the advertising notice shall correspond to those in the apothecary. the amounts specified in respect of cost substantiated discounts.
3)
We've got a sample of 10%. -However, at least 5 of them. and the most 25 of them. -checked whether the discounts received are in accordance with the prepared and published information on the availability of cost-founded discounts. The check has been based on the apothecary. stored documentation concerning cost-founded discounts, including documentation, in the form of invoices and credits, as set out in the section 33 of the advertising notice paragraph 33 (3). 2 >. The checks shall therefore not include a review of the physical conditions lying on the basis of the documentation indicated on the discounts received.
< 4a)
Only apothecary chains : we have checked that the tally of the apothecary chain obtained and received discounts are consistent with the discounts of the individual pharmacists. We're fetning confirmation from 10%. of the members of the Member States, but not less than five pharmacies and the highest 25 pharmacies-on the discounts received. >
4)
We've got a sample of 10%. -However, at least 5 of them. and the most 25 of them. -checked whether there is a clear basis for the assumption that discounts have been received which are outside the framework of the rules in the section 29-31 of the advertising notice section 29-31 and sections 36 and 37 (6) and 37 (3). 1 >. The check has been based on the apothecary. stored documentation concerning cost-reasoned discounts, including documentation in the form of invoices and credits, as set out in the section 33 of the advertising notice paragraph 33 (5). 2 >. The checks shall therefore not include a review of the physical conditions lying on the basis of the documentation indicated on the discounts received.
For marketing activities :
5)
We've got a sample of 10%. -However, at least 5 of them. and the most 25 of them. -checked if the apothecary keep records of the marketing activities services, including for received sponsorships, representation, etc., which are not part of the apothecary ; accounting items and are not considered to be of the insignificant value, cf. Section 21 (1). Two, in the advertising notice.
< 6a)
Only apothecary chains : We have checked the sum of the amounts of the apothecary chain regarding contracts for marketing activities concluded by the chain on behalf of the members of the Member States and checked that they are consistent with the individual requirements ; apothecary amounts of the amount. We're fetning confirmation from 10%. of the members of the Member States, but not less than five pharmacies and a maximum of 25 apothecs-on the amounts received. >
6)
We have checked that the tally of the documented amounts for marketing activities are in line with those in the pharmacy, the amounts specified in respect of marketing activities ;
7)
We've got a sample of 10%. -However, at least 5 of them. and the most 25 of them. -checked whether there is a clear basis for the assumption that there are any marketing benefits that are outside the framework of the rules of Chapter 7 of the advertising notice. The check has been based on the apothecary. kept records of the received marketing services received. The checks shall therefore not include a review of the physical characteristics of the data stored in the stored documentation for information on received marketing benefits.
Actual results
We have found the following conditions :
1)
For example, no comments.
2)
For example, we found that the tally is in line with the amounts indicated in the accounts concerning cost-founded discounts.
3)
For example, we have found that the sample was found that ...
< 4a)
For example, we found that the tally of the apothecary chain obtained and received discounts were consistent with the discounts of the individual pharmacies. We have received confirmation from x apothecks that they from the apothecary chain passed discounts voting with the received discounts of the individual apothecary.
4)
For example, no comments.
5)
For example, no comments.
< 6a)
For example, we found that the sum of the amount of the apothecary chain was received regarding the marketing activities agreements concluded by the chain on behalf of the members of the Member States to the individual pharmacies. We have received confirmation from x apothecks that they from the apothecary chain passed the amount of the amount received by the individual apothecary. >
6)
For example, we found that the tally is in line with the amounts indicated in the accounts relating to marketing activities.
7)
Example : No comments
(Actual results must include adequate errors and exceptions found.).
Date :
______________________________
(State sautorist/registered auditor)