Regulation (2009:929) Concerning Trade In Certain Over-The-Counter Drugs

Original Language Title: Förordning (2009:929) om handel med vissa receptfria läkemedel

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Read the untranslated law here: http://rkrattsbaser.gov.se/sfst?bet=2009:929

Introductory provisions



1 §/expires U: 2016-01-01/

This regulation prescribes that connects to

Act (2009:730) on trade in some non-prescription medicines. The

terms and concepts used in the Act have the same meaning in

This regulation.



1 section/entry into force: 01/01/2016

This regulation prescribes that connects to

Act (2009:730) on trade in some non-prescription medicines. The

terms and expressions used in the Act have the same meaning in

This regulation. Regulation (2015:463).



The Swedish medical products Agency's decision



section 2 of the food and drug administration shall, within 60 days of a

drugs have been classified as prescription decide if

whether the drug should be sold at other

outlets than outpatient pharmacies.



The Swedish medical products Agency's notice to municipalities



section 3 of the FDA will notify those municipalities where

the retail trade is conducted if a notification under section 9 or 10 teams

(2009:730) on trade in some non-prescription medicines.



Fee



4 § retailers under the Act (2009:730) if

trade in some non-prescription medicinal products, to

Agency to pay an annual fee for the work's supervision with

1 600 SEK per sales outlet.



Additional regulations on fees, see

fee Regulation (1992:191).



Whistleblowing schemes



§ 5 Of the E-hälsomyndigheten will be able to keep statistics

According to section 16 of the Act 4 (2009:730) on trade in some non-prescription

medicines, to retailers under the same law

each month send information to the Agency about the drug

that have been sold in the previous month.



The data shall include information on



1. name of the medicinal product,



2. pharmaceutical form,



3. strength,



4. pack size,



5. the number of packs sold,



6. sales date, and



7. sales price.



In the case of distance sales is also the customer's zip code

specified.



The information referred to in the first subparagraph shall be provided per

sales transaction separately for each sales point.

Information must be received by e-mail hälsomyndigheten within seven

days from the last day of the month following

the month in which the report relates. The data to be transferred

electronically. Regulation (2013:1043).



Appropriations



section 6 of the MPA may provide for



1. own the control under section 16 of the Act 1 (2009:730) on trade in

certain prescription drugs,



2. premises in accordance with section 16 of Act 2 with some non-prescription

medicines,



3. the provision under paragraph 16 of the 3 Act concerning trade in certain

non-prescription medicines, and



4. the design and control of the COMMUNITY logo as referred to in

16 a of the 2 teams (2009:730) on trade in some non-prescription

medicines. Regulation (2015:202).



section 7 of the MPA may provide for

the enforcement of the law (2009:730) concerning trade in certain

OTC drugs and of this regulation.