Law (2009:730) On Trade In Some Non-Prescription Medicines

Original Language Title: Lag (2009:730) om handel med vissa receptfria läkemedel

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Read the untranslated law here: http://rkrattsbaser.gov.se/sfst?bet=2009:730

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.