section 1 of this Act contains provisions on the retail sale of
some nonprescription drugs at other outlets than
community pharmacies.
section 2 of the retail trade shall be conducted in such a way that
the drugs do not harm people, property or the environment, and so
to maintain the quality does not deteriorate.
paragraph 3 of the rules on öppenvårdsapotekens retail is in
Act (2009:366) on trade in drugs.
Definitions
4 section With retail sales referred to in this Act of
drugs to consumers.
With nicotine medicines referred to in this law without a prescription
that has not been prescribed and whose sole active ingredient is
nicotine.
With community pharmacies are referred to in this law such an establishment
for the retail sale of medicinal products is carried out with permission
According to Chapter 2. section 1 of the Act (2009:366) on trade in drugs.
§ 5/expires U: 2016-01-01/
In this law, terms and concepts that are also present in
the medicines Act (1992:859) has the same meaning as in the Act.
§ 5/entry into force: 01/01/2016
In this law, terms and expressions that are also present in
the medicines Act (2015:315) has the same meaning as in the Act.
Law (2015:325).
Which drugs can be sold
6 § retail at other outlets than
community pharmacies may be carried out with
1. nicotine medicines, and
2. other non-prescription medicinal products that have not been prescribed
If
a) the drug is suitable for self-care,
(b)) serious adverse reactions are rare when using
the drug, and
(c)) it is appropriate to patient safety and
protection of public health.
section 7 of the food and Drug Administration will decide which medicines
meets the requirements of section 6 of the 2.
section 8 if a drug no longer meets the requirements of section 6 (2),
FDA may decide that the retail sale of medicinal product
may only be conducted at outpatient pharmacies.
Notification of trade
§ 9 a trader must not carry out retail activities in accordance with
This law, without first having notified the trade to
The medical products agency.
Notification of significant changes
section 10 of The retailers, the National Agency for medicines
report significant changes in the business. The notification shall
be made before the change is implemented.
Retail in serving areas
section 11 of the retail trade, with the exception of retail sale of
nicotine medications, do not take place in serving areas where
licence valid in accordance with Chapter 8. section 1 of the alcohol Act
(2010:1622). Law (2010:1634).
Age limit
section 12 At retail under this law may not
sold to anyone who has not reached 18 years of age.
The selling of medicines shall ascertain that the consumer
18 years of age.
13 § Nicotine medicines may not be sold if there is special
reason to believe that the drug is intended to be handed over
to anyone under the age of 18 years.
section 14 Where retail trade is conducted, there should be a clear and
clearly visible sign with information about the prohibition in section 12 and,
carrying out retail of nicotine medications, even if
the prohibition in section 13.
Pharmaceutical advice
section 15 retailers to inform consumers
If he or she can get pharmaceutical advice.
Requirements for business
16 §/expires U: 2016-04/12/
Retailers should
1. exercising specific control (self-check) over retail
and management of other drugs and ensure that it
a self-inspection program appropriate for your business,
2. operate in facilities appropriate for their
purposes,
3. provide the drugs appropriately, and
4. to email hälsomyndigheten providing the information is
necessary for the authority to keep statistics on
the retail trade. Team (2013:1029).
16 section/entry into force: 04/12/2016
Retailers should
1. exercising specific control (self-check) over retail
and management of other drugs and ensure that it
a self-inspection program appropriate for your business,
2. operate in facilities appropriate for their
purposes,
3. provide the drugs appropriately,
4. to email hälsomyndigheten providing the information is
necessary for the authority to keep statistics on
retail, and
5. check the safety features referred to in Chapter 4.
Article 1, second subparagraph the medicines Act (2015:315) on the medicines
as the operator handle. Law (2015:333).
16 a of the retailers of prescription
medicinal products for human use pursuant to lagen (2002:562) on electronic commerce
and other information society services shall, except as
set out in paragraph 16 of the even
1. ensure that the medicines complies with the requirements of national
legislation on the approval of the State within the European
economic area that sells to, and
2. on the site in which they offered have
contact information for Läkemedsverket and a hyperlink to a
website in accordance with article 85 c (4) of Directive 2001/83/EC
of 6 november 2001 on the Community code relating to
medicinal products, as last amended by European Parliament and
Council directive 62/EU and clearly display an EU logo.
Team (2013:42).
Supervision
section 17 of the FDA has oversight over compliance with this
law and by the regulations issued in connection
to the law.
section 18 the FDA has the right to request the
information and documents needed for supervision.
For the exercise of supervision has the FDA the right to
access to areas, offices and other facilities
used in conjunction with retail and management in General
of medicines. The FDA receives in such spaces make
examinations and taking samples. For the outlet sample paid no
compensation. The FDA has not under this Act
right of access to housing.
On request, the who possesses drugs leave
necessary assistance in the investigation.
section 19 of the food and Drug Administration may announce the injunctions and prohibitions
needed to this Act or the regulations that have
a court in connection with the law should be complied with.
Decision on the injunction or prohibition may be subject to a penalty.
Control
section 20 of the municipality in which the retail trade is conducted to check
compliance with this Act and the regulations that have
a court in connection with the Act.
section 21 of the municipality has the right to request the information and
documents needed for control.
In order to carry out its tasks, the municipality has the right to
access to areas, offices and other facilities
used in conjunction with retail and management in General
of medicines. The municipality does not have the right under this Act
to access to housing.
The municipality shall to the MPA report deficiencies in the
compliance with this Act and the regulations that have
a court in connection with the Act.
section 21A in order to provide a basis for a dialogue between the municipality
and anyone who sells drugs on the obligation to ensure
If the recipient has reached the age laid down in section 12,
the municipality carry out the control purchase. When such a purchase may
the municipality only hire a person who has reached the age of 18.
A control purchases may be carried out without the trader
be informed in advance if the control purchase. The municipality shall, as soon as possible
After a completed control purchase, inform the trader about
control purchase. Law (2014:120).
21 b of the information gained through the control purchase must not be
basis for the FDA to announce orders or
prohibition under section 19.
The Government or the authority that the Government may
provide for the implementation of the control purchase.
Law (2014:120).
Fees
section 22 retailers under this Act shall
pay an annual fee to the Agency for the work's
supervision.
The Government may provide for the amount.
section 23 of a municipality may, for its control under this law to take out
fee by retailers.
Liability, etc.
section 24 of The who willfully or negligently violates 9
or paragraph 12 shall be liable to a fine or imprisonment
a maximum of six months.
In minor cases should not be tried for responsibility.
section 25 of The who have violated a penalty payment mechanism or a
injunction should not incur liability under this Act for
acts covered by the injunction or prohibition.
section 26 of the drugs that have been the subject of a crime under this
law or its value as well as the exchange of such breach,
be declared forfeited, unless it is manifestly unfair.
Appeal
section 27 of the medical products Agency's decision under this Act may be appealed
in general administrative court if the decision concerns
1. where a medicinal product should be sold at other
outlets than outpatient pharmacy, or
2. the injunction or prohibition.
Other decisions by the FDA under this Act, or
regulations that have been issued in connection with the Act,
not subject to appeal.
Leave to appeal is required for an appeal to the administrative court.
FDA decisions or general administrative courts
notify under this Act shall be effective immediately, unless otherwise
specified in the decision.
Appropriations
section 28 of the Government or the authority, as the Government determines
may provide for
1. own the control referred to in section 16 (1),
2. premises referred to in section 16 (2),
3. the provision under paragraph 16 of the 3, and
4. the design and control of the COMMUNITY logo as referred to in
16 (a), paragraph 2. Team (2013:42).
Transitional provisions
2009:730
1. this law shall enter into force on 1 January 2009 when the Act
(2007:1455) on retail sale of nicotine medications should cease
to apply.
2. A notification under paragraph 3 of the Act (2007:1455) on retail
with nicotine medicines shall apply as a notification under section 9
This law, however, only in so far as it relates to retail with
nicotine medicines.
3. Older rules still apply for decisions before the
entry into force has been issued on the basis of law (2007:1455)
If the retail sale of nicotine medicines.
4. in the case of medicinal products for human use on October 31, 2009
classified as a prescription and which are not
nicotine medications, medical products agency by 31 december
2009 for each individual drug product should decide about getting
sale to the final consumer at the other outlets than
community pharmacies. If the Agency has not taken a
such a decision by 31 december 2009, the medicine should
then be sold at other outlets than
community pharmacies.
2016:134
The Government states that the Act (2013:41) amending the Act (2009:730) concerning trade in certain over-the-counter medicines shall enter into force on 12 april 2016. The provisions on security details for the first time three years after the Commission delegated Regulation (EU) no 2016/161 of 2 October 2015 on the completion of a European Parliament and Council Directive 2001/83/EC by establishing detailed rules concerning the security details as indicated on the packaging of medicinal products for human use has been published in the official journal.
