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.
