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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Read the untranslated law here: https://www.retsinformation.dk/Forms/R0710.aspx?id=115525

Ordinance amending the Ordinance on pharmacists ' and pharmacy chains reporting

§ 1

In executive order No. 266 of 21. March 2007 on pharmacists ' and pharmacy chains reporting is amended as follows:

1. In section 17 is inserted after 1. item:» the statement of assurance shall be replaced by the following Annex 1 showed in the template for the Declaration of assurance by the pipe clean the pharmacists ' and pharmacies chains about diet nings be reason ede discounts and marketing activities. '.

2. In section 19 is inserted after 1. item:» the statement of assurance shall be replaced by the following Annex 1 showed in the template for the Declaration of assurance by the pipe clean the pharmacists ' and pharmacies chains about diet nings be reason ede discounts and marketing activities. '.

3. In section 24 shall be inserted after 1. item:» the statement of assurance shall be replaced by the following Annex 1 showed in the template for the Declaration of assurance by the pipe clean the pharmacists ' and pharmacies chains about diet nings be reason ede discounts and marketing activities. '.

4. In section 26 is inserted after 1. item:» the statement of assurance shall be replaced by the following Annex 1 showed in the template for the Declaration of assurance by the pipe leaked proprietary pharmacists and pharmacy chains about diet nings be reason ede discounts and marketing activities. '.

5. Annex 1 is replaced by the text in annex 1 to this notice.

§ 2

The notice shall enter into force on 16 September. March 2008.
The Ministry of health and prevention, 12. March 2008 Jakob Axel Nielsen/Paul Schüder Annex 1

Template for the preparation of the statement of assurance concerning pharmacists ' and pharmacy chains cost justified discounts and marketing activities







 





Declaration of independent auditor





 





To The Danish Medicines Agency





 





Introduction







Upon agreement we have carried out the work actions, which are listed below on the pharmacy's cost justified discounts and marketing activities, see. sections 17 and 19 of Decree No. 266 of 21. March 2007 on pharmacists ' and pharmacy chains reporting. Our statement has been prepared for the Pharmacy and medicines use for the purpose referred to in this Declaration.







The goal of the agreed actions is that we work as auditors carrying out the audit similar labour actions relating to Apoteket's cost justified discounts and marketing activities, as is required by the Ministry of Health and prevention audit instructions of 25. February 2008. We declare ourselves about the results of the audit performed similar work on the actions below, in the section "Actual results".







The following working operations are performed in accordance with the Danish auditing standard on agreed labour actions. Since the following working operations are not audit or review in accordance with Danish auditing standards thereof, pronounce ourselves alone on the actual results of the performed work acts and thus does not express a conclusion with certainty whether pharmacies alone have received cost-justified discounts and amounts relating to marketing activities within the applicable rules to that effect.







If we had carried out further work actions, revised or completed the review in accordance with Danish auditing standards for doing so, could other conditions might be found and reported, and since the Declaration only concerns the conditions mentioned below, it cannot be extended to cover the pharmacy's accounts as a whole.





 





Performing actions







Our work is carried out in accordance with the Danish auditing standard on agreed labour actions.







Our actions can be summarised as follows: worked





 





Concerning cost justified discounts:







1)





We have a sample of 10 per cent – a minimum of 5 and maximum 25 paragraph – controlled about pharmacies shall keep evidence, in the form of invoices and credit notes, concerning cost justified discounts, as stated in section 33 in the advertising order.







2)





We have verified that the total of the amounts as documented, see. section 33 of the advertising order, correspond to the amounts in the pharmacy's accounts concerning cost justified discounts.







3)





We have a sample of 10 per cent – a minimum of 5 and maximum 25 paragraph – checked if they received discounts are in accordance with the discount ' produced and published information about access to achieve cost-justified discounts. Control has been based on the of the pharmacist stored documentation relating to cost-justified discounts, including documentation in the form of invoices and credit notes, as stated in paragraph 33 of the Executive order on advertising. Therefore not an audit examination includes inspection of the physical conditions that form the basis for the information referred to in the evidence stored on received discounts.















4)





We have a sample of 10 per cent – a minimum of 5 and maximum 25 paragraph – checks whether there are apparent grounds for believing that received rebates, which is beyond the scope of the rules in sections of the Executive order on advertising 29-31. Control has been based on the of the pharmacist stored documentation relating to cost-justified discounts, including documentation in the form of invoices and credit notes, as set out in section 33 of the Executive order on advertising. Therefore not an audit examination includes inspection of the physical conditions that form the basis for the information referred to in the evidence stored on received discounts.





 





Concerning marketing activities:







5)





We have a sample of 10 per cent – a minimum of 5 and maximum 25 paragraph – checks whether the pharmacist shall keep evidence for services relating to marketing activities, including for received sponsorships, representation, etc., which are not part of the pharmacy's accounting records, and are not considered to be of negligible value, see. Article 21, paragraph 2, of the advertising order.















6)





We have verified that the count of the documented amounts relating to marketing activities correspond to the accounts listed in the pharmacy's amounts related to marketing activities.







7)





We have a sample of 10 per cent – a minimum of 5 and maximum 25 paragraph – checks whether there are apparent grounds for believing that received marketing services outside the framework of the rules set out in Chapter 7 of the Executive order on advertising. Control has been based on the of the pharmacist stored documentation relating to the marketing of services received. Therefore not an audit examination includes inspection of the physical conditions that form the basis for the information referred to in the documentation stored on the marketing benefits received.





 





Actual results







We have found the following conditions:







1)





Example: No comments.







2)





Example: We found that the count match the amounts in the financial statements regarding cost-justified discounts.







3)





Example: we have the sample found that ...















4)





Example: No comments.







5)





Example: No comments.















6)





Example: We found that the count match the amounts in the financial statements relating to marketing activities.







7)





Example: No comments





 





(Actual results must include sufficient details about found errors and exceptions).





 



 





Date:






 





______________________________







(Chartered/Certified Accountant)