Law (2009:366) On Trade In Pharmaceuticals

Original Language Title: Lag (2009:366) om handel med läkemedel

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Read the untranslated law here: http://rkrattsbaser.gov.se/sfst?bet=2009:366

Chapter 1. Initial provisions and definitions



paragraph 1 of this law provides for



-retail sale of medicines to consumers (Chapter 2),



-wholesale distribution of medicinal products (Chapter 3),



-brokering of medicinal products for human use (3 a Cape.)



-retail sale of medicines to health care

(Chapter 4),



-Hospital drug supplies (Chapter 5.)



-mechanical single dose distribution at community pharmacies (Chapter 6),



-supervision (Chapter 7),



-handling, fees and withdrawal of permits

(Chapter 8), and



-responsibility, confiscation, appeal and further

authorization (Chapter 9). Team (2013:38).



section 2 of the trade in medicinal products should 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.



3 §/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.



It as in this Act provided, in the case of medicinal products should also

apply to goods and product groups referred to in paragraph 3 of the medicines Act.



3 section/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.



It as in this Act provided, in the case of medicinal products should also

apply to goods and product groups as referred to in chapter 18. section 2 of the

the medicines Act. Law (2015:323).



section 4 of this Act, the following definitions shall apply the following

importance.



Retail sale of pharmaceutical products to the consumer,

Medical Association, hospital or other

medical facility or to the

jurisdiction to order medicines.



Dose delivery completion of medicines for

individual's needs during a certain period of time by

removal from the manufacturer's

original packaging.



Intermediation Activities related to

the sale or purchase of humanäkemedel

and that is not considered to be wholesale

and that occurs without physical handling by

independent negotiation for a legal

or natural person.



Wholesale activities consisting of procuring,

the possession, export, delivery or such

the sale of medicinal products which are not

considered retail.



Hospital pharmacy The function or the activities

cater to the pharmaceutical supply to

or in the hospital.



Caregivers natural or legal person who

occupation health

medical care.



Outpatient pharmacy facility for retail trade in medicinal products

carried out with authorization pursuant to Chapter 2.

§ 1.

Team (2013:38).



Relationship to other laws



§ 5/expires U: 2016-01-01/

Provisions on information, marketing, order

and disclosure of the drugs found in the medicines Act

(1992:859).



At the retail sale of certain OTC drugs at other

outlets than outpatient pharmacies, valid

the provisions of the Act (2009:730) concerning trade in certain

non-prescription medicines. Law (2009:733).



§ 5/entry into force: 01/01/2016

Provisions on information, marketing, order

and disclosure of the drugs found in the medicines Act

(2015:315).



At the retail sale of certain OTC drugs at other

outlets than outpatient pharmacies, valid

the provisions of the Act (2009:730) concerning trade in certain

non-prescription medicines. Law (2015:323).



Chapter 2. Retail sale of medicines to consumers



Condition



1 §/expires U: 2016-01-01/

Only those who have received the medical products Agency's permit may

retail products to the consumer with such

medicines



1. approved for sale or subject to a

recognition of an authorisation as referred to in paragraph 5, first subparagraph

the medicines Act (1992:859),



2. the first subparagraph of paragraph 5 of the medicines Act may be sold

without authorization, registration or recognition of a

approval or registration,



3. for which authorisation for sale submitted pursuant to paragraph 5 of the

the third paragraph of the medicines Act, or



4. authorised by the European Commission

or the Council of the European Union. Law (2010:1324).



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

Only those who have received the medical products Agency's permit may

retail products to the consumer with such

medicines



1. authorised, subject to acknowledgement of the

an authorisation or subject to authorisation in accordance with Chapter 5. 1 §

first subparagraph, the medicines Act (2015:315),



2. in accordance with Chapter 5. the third subparagraph of paragraph 1 of the medicines Act,

be sold without authorization, registration or recognition of a

approval or registration, or



3. authorised by the European Commission or

The Council of the European Union. Law (2015:323).



section 2 of the approved retail herbal and medicinal products

approved for certain topical medications may be provided

without permission according to § 1.



paragraph 3, an authorisation under paragraph 1 shall relate to a particular

outpatient Pharmacy and shall apply until further notice.



Application review



section 4 authorisation under paragraph 1 may be granted only

showing that he or she is with respect to their personal and

economic conditions and circumstances are otherwise

appropriate to exercise activities and has the potential to

comply with the requirements of paragraph 6.



§ 5/expires U: 2016-01-01/

The authorisation required under paragraph 1 shall not be granted to the



1. professionally engaged in the manufacture of medicinal products or

intermediate products,



2. as the holder of a marketing authorisation for medicinal products,



3. who is authorized to order medicines,



4. over which a person referred to in 1 or 2 has a

controlling interest,



5. who exercises a dominant influence over a person

referred to in 1 or 2, or



6. over which a person referred to in 3, alone or

along with some other referred to in 3, have a

non-controlling interest.



With the exception of that referred to in the first subparagraph 1,

permission is granted for the manufacture refers only to the



1. single dose distribution,



2. medicinal products in accordance with paragraph 5 of the first paragraph the medicines Act

(1992:859) can be sold without authorization, registration or

recognition of an authorisation or registration, or



3. repackaging of pharmaceutical products.



With the exception of that referred to in the first subparagraph 2 shall

permission granted to the holder of the approval only for

the sale of parallel imported pharmaceuticals.



If there are special reasons, the FDA may allow

further exemptions from the prohibition against granting permission.

Law (2009:734).



§ 5/entry into force: 01/01/2016

The authorisation required under paragraph 1 shall not be granted to the



1. professionally engaged in the manufacture of medicinal products or

intermediate products,



2. as the holder of a marketing authorisation for medicinal products,



3. who is authorized to order medicines,



4. over which a person referred to in 1 or 2 has a

controlling interest,



5. who exercises a dominant influence over a person

referred to in 1 or 2, or



6. over which a person referred to in 3, alone or

along with some other referred to in 3, have a

non-controlling interest.



With the exception of that referred to in the first subparagraph 1,

permission is granted for the manufacture refers only to the



1. single dose distribution,



2. medicinal products as referred to in Chapter 5. Article 1, third paragraph

the medicines Act (2015:315) can be sold without approval,

registration or recognition of an authorisation or

registration, or



3. repackaging of pharmaceutical products.



With the exception of that referred to in the first subparagraph 2 shall

permission granted to the holder of the approval only for

the sale of parallel imported pharmaceuticals.



If there are special reasons, the MPA in the

individual case allow additional exceptions from the prohibition against

to grant the permission. Law (2015:323).



Requirements for business



6 §/expires U: 2016-04/12/

Anyone who has a permit under section to carry out retail activities

with drugs to the consumer,



1. have premises manned with one or more pharmacists in

opening hours,



2. operate in facilities appropriate for their

purposes,



3. provide all authorized medicinal products, and all

ordered goods covered by law (2002:160) if

pharmaceutical benefits, etc.,



4. have a drug responsible for the pharmacy,



5. When dispensing a prescription with data

specified in §8 of the Act (1996:1156) on prescription records to

E-hälsomyndigheten,



6. have an electronic system which makes it possible to get

direct access to data by e-mail hälsomyndigheten,



7. to e-mail hälsomyndigheten with data is

necessary for the authority to keep statistics on

retail trade,



8. exercise special control (self-check) over retail

and management, and ensure that there is a

activities appropriate the self-inspection program,



9. at the request of certification according to 3 a of the Act (1992:860) om

drugs,



10. on request offer consumers some payment of medicines

and the goods covered by the law on pharmaceutical benefits, etc.,



11. provide individual and manufacturer independent

information and advice about drugs, drug use


and self-care to consumers and ensure that the information

and advice are provided only by professionals with adequate

competence for the task,



12. have a FDA registered trademark for

outpatient pharmacy prominently displayed on the pharmacy, and



13. in cases where the licensee is not directly

provide a medicinal product or a product referred to in (3),

inform the consumer of the language or

outpatient pharmacy medicinal product or software is available for

sale. Law (2014:462).



6 §/entry into force: 04/12/2016

Anyone who has a permit under section to carry out retail activities

with drugs to the consumer,



1. have premises manned with one or more pharmacists in

opening hours,



2. operate in facilities appropriate for their

purposes,



3. provide all authorized medicinal products, and all

ordered goods covered by law (2002:160) if

pharmaceutical benefits, etc.,



4. have a drug responsible for the pharmacy,



5. When dispensing a prescription with data

specified in §8 of the Act (1996:1156) on prescription records to

E-hälsomyndigheten,



6. have an electronic system which makes it possible to get

direct access to data by e-mail hälsomyndigheten,



7. to e-mail hälsomyndigheten with data is

necessary for the authority to keep statistics on

retail trade,



8. exercise special control (self-check) over retail

and management, and ensure that there is a

activities appropriate the self-inspection program,



9. at the request of certification according to 3 a of the Act (1992:860) om

drugs,



10. on request offer consumers some payment of medicines

and the goods covered by the law on pharmaceutical benefits, etc.,



11. provide individual and manufacturer independent

information and advice about drugs, drug use

and self-care to consumers and ensure that the information

and advice are provided only by professionals with adequate

competence for the task,



12. have a FDA registered trademark for

outpatient pharmacy prominently displayed on the pharmacy,



13. in cases where the licensee is not directly

provide a medicinal product or a product referred to in (3),

inform the consumer of the language or

outpatient pharmacy medicinal product or software is available for

sales, and



14. check the safety features referred to in Chapter 4.

Article 1, second subparagraph the medicines Act (2015:315) on the

medicinal products for which the holder of the handling. Law (2015:334).



Age limit



6 a of non-prescription drugs that are not prescribed, and whose

only one active ingredient is nicotine (nicotine medications) may not

sold to anyone who has not reached 18 years of age.



The selling nicotine medicines shall ascertain that the

the consumer is at least 18 years of age. Law (2009:733).



6 b of 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. Law (2009:733).



section 6 c Of the community pharmacies, there should be a clear and

clearly visible sign with information about the bans in 6 (a) and

6 (b) sections. Law (2009:733).



Pharmaceutical Manager



section 7 A pharmaceutical Manager shall ensure that the activities of the

öppenvårdsapoteket fulfils the requirements of

retail sales and management in General.



If there is, or is likely to occur serious deficiencies

or serious adverse events in its activity, the

Pharmaceutical Officer promptly report it to the FDA.



§ 8 the task that the pharmaceutical officer has under section 7

may include up to three community pharmacies.



If there are special reasons, the Agency may decide to

a drug charge may be responsible for more than three

community pharmacies.



§ 9 the licensee shall notify the National Agency for medicines who

who is responsible for this drug.



Only pharmacists, pharmacist or another with sufficient

skills and experience for the job, may be appointed to

pharmaceutical representative.



Notification of significant changes



section 10 the licensee shall notify the National Agency for medicines

significant changes in the business. The notification shall be made

before the change is implemented.



Distance trade



10 a of retailers of medicinal products to

consumer pursuant to lagen (2002:562) on electronic commerce and

other information society services shall, except as provided

in paragraph 6, 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 to have contact information

the National Agency for medicines, and a hyperlink to a Web site 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 (2013:40).



Obligation to provide for E-hälsomyndigheten



10 b of E-hälsomyndigheten shall inform the Agency of

the results of the verification of the electronic system

for direct access to the data by the authority as a

licence holders shall be in accordance with paragraph 6 6. The authority shall forward

notify the FDA if a licensee does not leave

the information to the authority provided for in section 6, 5 and 7.

Team (2013:1025).



Appropriations



section 11 of the Government or the authority, as the Government determines

may provide for



1. design of the premises referred to in paragraph 6 of the 2,



2. the period within which the provision under section 6, 3 shall be carried out,



3. what skills and experience in a pharmaceutical responsible according to

6 § 4 shall have,



4. own the control under section 6, 8,



5. use of the trade mark as referred to in paragraph 6 of the 12, and



6. the design and control of the COMMUNITY logo as referred to in paragraph 10 (a)

2. team (2013:40).



Chapter 3. Wholesale distribution of medicinal products



Condition



Article 1, only those who have been granted permission to wholesale

or production in a State of the European economic

area may engage in activity as a wholesaler in medicinal products. The

granted permission to manufacture may perform the

wholesale only with medicinal products which are covered by

the manufacturing authorisation.



Agency may grant authorisation for wholesale only

to it showing that it has the potential to meet

the requirements of paragraph 3. Team (2013:38).



section 2 of a permit in accordance with paragraph 1 shall be valid for certain period of time.



Requirements for business



3 §/expires U: 2016-01-01/

Anyone who engages in the wholesale distribution of medicinal products under section

should



1. operate in facilities appropriate for their

purposes,



2. to e-mail hälsomyndigheten with data is

necessary for the authority to keep statistics on

wholesale trade,



3. document the management of drugs in such a manner that

they can be traced,



4. at his disposal an expert who shall ensure that

requirements on safety and quality of medicines are met,



5. exercise special control (self-check) over the wholesale trade

and management, and ensure that there is a

activities appropriate the self-inspection program,



6. to community pharmacies deliver the drugs covered

of the permit;



7. distribute the only medicines that may be sold in accordance with paragraph 5 of

the medicines Act (1992:859) or is investigational

According to the third subparagraph of paragraph 1 of the same law,



8. obtain drugs only from those who may perform the

wholesale distribution of medicinal products, and conducting any trading in

accordance with good distribution practice,



9. obtaining medicines from the brokering medicinal products

only if the Agency is carried out in accordance with Chapter 3 (a),



10. supply medicinal products only to persons who are authorized to

wholesale or retail trade in medicinal products, or have notified

retail trade of certain prescription drugs,



11. immediately notify the FDA and

case the holder of the marketing authorisation for

the product upon receipt or offer of

medicinal products for which the licensee considers is or can

be falsified, and



12. otherwise follow good distribution practices.

Team (2013:1025).



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

Anyone who engages in the wholesale distribution of medicinal products under section

should



1. operate in facilities appropriate for their

purposes,



2. to e-mail hälsomyndigheten with data is

necessary for the authority to keep statistics on

wholesale trade,



3. document the management of drugs in such a manner that

they can be traced,



4. at his disposal an expert who shall ensure that

requirements on safety and quality of medicines are met,



5. exercise special control (self-check) over the wholesale trade

and management, and ensure that there is a

activities appropriate the self-inspection program,



6. to community pharmacies deliver the drugs covered

of the permit;



7. distribute the only medicines that may be sold according to Chapter 5.

section 1 of the medicines Act (2015:315) or is investigational

According to Chapter 2. paragraph 1 of the same law,



8. obtain drugs only from those who may perform the

wholesale distribution of medicinal products, and conducting any trading in

accordance with good distribution practice,



9. obtaining medicines from the brokering medicinal products

only if the Agency is carried out in accordance with Chapter 3 (a),



10. supply medicinal products only to persons who are authorized to

wholesale or retail trade in medicinal products, or have notified

retail trade of certain prescription drugs,



11. immediately notify the FDA and


case the holder of the marketing authorisation for

the product upon receipt or offer of

medicinal products for which the licensee considers is or can

be falsified, and



12. otherwise follow good distribution practices.

Law (2015:323).



3 a § § 3 b/new letter U: 2016-04/12/

As indicated in paragraph 3 of the 2, 7 and 10 shall not apply to

wholesale distribution of medicinal products to a State outside the European

economic area. As indicated in paragraph 3 of the 8 does not apply

When a medicinal product is received directly, without having to be imported,

from the same area. As indicated in paragraph 3 of the 6 is in addition to the

has been granted permission to conduct wholesale only

manufacturers who also is the holder of the marketing authorisation

sales of the drugs wholesale concern.

As specified in section 3 does not apply to wholesale

veterinary medicinal products to a State outside the European

economic area, or when a veterinary

drugs are received directly, without importing them, from the same

area. Team (2013:38).



3 a section/entry into force: 04/12/2016

The operator of wholesale under section 1 shall also

check the safety features referred to in Chapter 4. 1 §

second subparagraph, the medicines Act (2015:315) for medicinal products for human use

as the holder of the handling. Law (2015:329).



3 b/entry into force: 04/12/2016

As indicated in paragraph 3 of the 2, 7 and 10 shall not apply to

wholesale distribution of medicinal products to a State outside the

The European economic area. As indicated in paragraph 3 of 8

and 3 a of does not apply when a medicinal product is received directly,

without imported, from the same area. As indicated in paragraph 3 of 6

In addition to the granted permission to conduct

wholesale only manufacturers who are also holders of

marketing authorisation for medicinal products

wholesale trade concerns.



As specified in section 3 does not apply to wholesale

veterinary medicinal products to a State outside the European

economic area, or when a veterinary

drugs are received directly, without importing them, from the same

area. Team (2013:39).



3 c § anyone who engages in the wholesale distribution of medicinal products under section

shall, with regard to trade in medicinal products with a State

outside the European economic area, including



1. in cases where the acquire medicines, the drug received directly

without imported, only from the authorized or

is competent to deliver the product in accordance with the rules in

the State in which the acquisition takes place, and



2. deliver the drugs only to the authorized or

is competent to receive medications for wholesale or for

disclosure to the public in accordance with the rules of the

State that the delivery is made to. Team (2013:519).



Notification of significant changes



4 § the licensee shall notify the National Agency for medicines

significant changes in the business. The notification shall be made

before the change is implemented.



Appropriations



section 5 of the Government, or the Government authority determines,

may provide for



1. design of the premises referred to in section 3, paragraph 1,



2. the documentation required pursuant to section 3 of 3,



3. what skills and experience as an expert according to

3 § 4 shall have,



4. own the control referred to in paragraph 3 of the 5, and



5. the period within which delivery according to paragraph 3 of the 6.



3 a Cape.



Brokering of medicinal products for human use



Notification



Article 1, only those who have a fixed address in a State of

European economic area and has notified

activities to a competent authority within the same State may

convey the human medicinal products intended to be placed on the

the market in the European economic area.

If the provider has a permanent address in Sweden, the business

be reported to the FDA. Team (2013:38).



Requirements for business



2 §/expires U: 2016-01-01/

The brokering medicinal products for human use shall



1. convey only such medicinal products that may be sold according to

paragraph 5 of the medicines Act (1992:859) or is investigational

According to the third subparagraph of paragraph 1 of the same law,



2. document management of drugs in such a manner that they

can be traced,



3. exercise special control (self-check),



4. immediately notify the FDA and

case the holder of the marketing authorisation for the medicinal product

If the medicine that the provider receives or is offered is

or is deemed to be counterfeit, and



5. otherwise follow good distribution practices. Team (2013:38).



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

The brokering medicinal products for human use shall



1. convey only such medicinal products which may be sold

According to Chapter 5. section 1 of the medicines Act (2015:315) or is

investigational medicinal products referred to in Chapter 2. paragraph 1 of the same law,



2. document management of drugs in such a manner that

they can be traced,



3. exercise special control (self-check),



4. immediately notify the FDA and

case the holder of the marketing authorisation for

the medicine of the medicine that the provider receives or

offered are or are deemed to be counterfeit, and



5. otherwise follow good distribution practices.

Law (2015:323).



Authorization



section 3 of the Government or the authority, as the Government determines

may announce further provisions concerning



1. What documentation is required under paragraph 2 of 2, and



2. own the control under paragraph 2 of 3. Team (2013:38).



Chapter 4. Retail sale of medicines to health care



§ 1 The authorized pursuant to Chapter 2. paragraph 1 may engage

retail sale of medicines to



1. Medical Association,



2. hospitals and other health institutions, as well as



3. a person who is authorized to order medicines.



The authorized pursuant to Chapter 3. Article 1, second subparagraph,



1. retail sale of medicines to health care Association

and hospitals, as well as



2. sell vaccines and serums to other health care facilities,

physicians and veterinary surgeons. Team (2013:38).



2 §/expires U: 2016-04/12/

Retailers under section shall

E-hälsomyndigheten provide the information necessary for

that the authority should be able to keep statistics on

the retail trade. Team (2013:1025).



2 section/entry into force: 04/12/2016

Retailers according to § 1 shall



1. to e-mail hälsomyndigheten with data is

necessary for the authority to keep statistics on

retail, and



2. check the safety features referred to in Chapter 4.

Article 1, second subparagraph the medicines Act (2015:315) on the

medicinal products for which the holder of the handling.

Law (2015:332).



Chapter 5. Hospitals ' drug supplies



section 1 of the health care provider shall organise the pharmaceutical supply to

and in the hospital in such a way that it is carried out

rational and so the need for safe and effective

drugs will be secured. For this purpose, there shall be

hospital pharmacies, which will be staffed with one or more

pharmacists.



Notification



section 2 of the health care provider shall notify the National Agency for medicines how

pharmaceutical supplies to and within hospitals should be

organized.



If the Organization of drug supply significantly

change, this shall be reported to the FDA.



section 3 of the event or risk serious

deficiencies in drug supply to or in hospital,

the health care provider shall promptly notify this to the FDA.



Authorization



section 4 of the Government, or the Government authority determines,

may provide for how the notification requirement in 2

and 3 sections to be performed.



Chapter 6. Mechanical single dose distribution at community pharmacies



Condition



1 §/expires U: 2016-01-01/

Only those who have received the medical products Agency's permit may

conduct mechanical single dose distribution in community pharmacies.



A permit may be granted, only that which shows that it has

conditions to meet the requirements of paragraph 15, second subparagraph

the medicines Act (1992:859).



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

Only those who have received the medical products Agency's permit may

conduct mechanical single dose distribution in community pharmacies.



A permit may be granted, only that which shows that it has

conditions to meet the requirements of Chapter 8. section 1 of the first

subparagraph, the medicines Act (2015:315). Law (2015:323).



section 2 of a permit in accordance with paragraph 1 shall relate to a particular

outpatient Pharmacy and shall apply until further notice.



Notification of significant changes



section 3 of the licensee shall notify the National Agency for medicines

significant changes in the business. The notification shall be made

before the change is implemented.



Chapter 7. Supervision



section 1 the agency oversees compliance with this

Act and of the regulations and conditions as given in

adherence to the law.



section 2 of the food and Drug Administration 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 the context of trade, production and management in

other drugs and packaging materials for medicinal products.

The FDA may conduct research in such areas

and take samples. For the outlet sample is paid no compensation.

The FDA does not have the right under this Act to

access to housing.



On request, the possession of drugs and

packaging materials for medicinal products provide necessary assistance

during the investigation.



section 3 of the FDA must notify the injunctions and prohibitions

needed to this Act or the regulations and conditions

in connection with the law should be complied with.



Decision on the injunction or prohibition may be subject to a penalty.




Chapter 8. Management, fees and withdrawal of permits



Processing



paragraph 1 of the Decision by the FDA for permission to conduct



1. retail sale of medicines to consumers pursuant to Chapter 2.

section 1,



2. wholesale trade of medicinal products as defined in Chapter 3. paragraph 1, and



3. mechanical single dose distribution of outpatient pharmacy in accordance with the

Chapter 6. 1 §



to be made within the time limit set by the Government.



Fees



section 2 of the food and Drug Administration may charge an application fee of the

applying for an authorisation to conduct



1. retail sale of medicines to consumers pursuant to Chapter 2.

section 1,



2. wholesale trade of medicinal products as defined in Chapter 3. paragraph 1, or



3. mechanical single dose distribution of outpatient pharmacy in accordance with the

Chapter 6. § 1.



As long as the permit is valid, the FDA take out a

annual fee of the licensee. The FDA may also

charge a renewal fee by retailers of

medicinal products as defined in Chapter 4. § 1 or driver hospital pharmacies under

Chapter 5. § 1.



The Government may provide for fees.

Team (2013:623).



2 a of E-hälsomyndigheten may charge a fee to



1. issue a certificate which proves that the applicant for

permission to conduct the retail sale of medicinal products to

the consumer has the potential to meet the requirements

provided in Chapter 2. 6 § 5 – 7, and



2. check the electronic system for direct access to

tasks of the authority that a licensee shall have

According to Chapter 2. paragraph 6 6.



A fee as referred to in the first subparagraph 1 shall be applied by the

applying for the permit. A fee as referred to in the first subparagraph 2 shall

put out by the licensee.



The Government may announce further provisions concerning

the fees. Team (2013:1025).



Revocation of authorization



section 3 A permit to conduct the retail sale of medicinal products

to the consumer according to Chapter 2. paragraph 1 may be withdrawn if the



1. suitability requirements in Chapter 2. paragraph 4 are not fulfilled,



2. the licensee does not meet the requirements laid down in

Chapter 2. section 6,



3. conditions are such that the State would not have

granted, because of the provisions of Chapter 2. § 5 If the ban

against granting permission, or



4. the licensee shall not report significant changes of

the activities referred to in Chapter 2. section 10.



paragraph 4 A permit to conduct wholesale distribution of medicinal products

According to Chapter 3. paragraph 1 may be withdrawn if the holder does not



1. meet the requirements laid down in Chapter 3. section 3, or



2. notify significant changes of activities under

Chapter 3. 4 section.



§ 5/expires U: 2016-01-01/

A permit to conduct mechanical single dose distribution on

community pharmacies in accordance with Chapter 6. paragraph 1 may be withdrawn if the

the licensee shall not



1. meet the requirements laid down in paragraph 15, second subparagraph

the medicines Act (1992:859), or



2. notify significant changes of activities under

Chapter 6. section 3.



§ 5/entry into force: 01/01/2016

A permit to conduct mechanical single dose distribution on

community pharmacies in accordance with Chapter 6. paragraph 1 may be withdrawn if the

the licensee shall not



1. meet the requirements laid down in Chapter 8. section 1 of the first

subparagraph, the medicines Act (2015:315), or



2. report significant changes to operations according to 6

Cape. section 3. Law (2015:323).



Chapter 9. Responsibility, confiscation, appeal and further

authorization



Responsibility



§ 1 the person willfully or negligently without permission



1. engages in such retail of medicinal products as laid down in

Chapter 2. section 1,



2. engaged in the wholesale distribution of medicinal products as defined in

Chapter 3. section 1,



3. According to Chapter 2. section 1 or 3. 1 § conduct such

retail trade in medicinal products as laid down in Chapter 4. paragraph 1, or



4. conducting any mechanical single dose distribution as specified in

Chapter 6. 1 §



shall be liable to a fine or imprisonment of up to one year, if the Act

is not subject to punishment under the criminal code.



To the penalties referred to in the first subparagraph shall be liable also

intentionally holding the drugs for the purpose of unlawfully selling

them.



In minor cases should not be tried for responsibility.



If a willful act referred to in the first subparagraph 1 – 3 or

in the second paragraph was committed professionally, intended major

quantity or value or otherwise of the particularly dangerous nature,

is sentenced to imprisonment not exceeding two years.



1 a of the one who intentionally or negligently violates

Chapter 2. 6 a of the first subparagraph shall be liable to a fine or imprisonment

a maximum of six months.



In minor cases should not be tried for responsibility. Law (2009:733).



section 2 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.



Forfeiture



paragraph 3 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



paragraph 4 of the decision of the Agency under this Act may be appealed

in general administrative court if the decision concerns



1. the permit referred to in Chapter 2. section 1, Chapter 3. § 1 or Chapter 6. section 1,



2. If a pharmaceutical Manager should be responsible for more than three

outpatient pharmacy pursuant to Chapter 2. section 8,



3. injunctions or prohibitions under Chapter 7. section 3, or



4. the withdrawal of authorisation pursuant to Chapter 8. 3, 4 or 5.



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.



Additional authorization



section 5 of the Government, or the Government authority determines,

may provide the additional regulations on trade in

medicines needed for the protection of human and animal life

or health and for the environment.



Transitional provisions



2009:366



1. this law (new law) will come into force on July 1, 2009

Act (1996:1152) on trade in drugs, etc. (old law)

shall be repealed.



2. The right to engage in retail trade in medicines

Apoteket Aktiebolag has according to the old law shall apply as

authorization under the new law until the State under

Chapter 2. section 1 of the new law have been announced, but not

June 30, 2010.



3. A permission to engage in activity as a wholesaler in medicinal products

has been granted in accordance with the old Act shall apply which permit

According to the new law.



4. Older rules still apply for decisions

granted prior to the entry into force.



5. Herbal medicinal product, as approved by 30 april 2006

that natural remedies and which after application is approved as

drugs under the medicines Act (1992:859) shall, if it is

question about drugs with the same strengths, dosages and

indications referred to in the decision of approval as

natural remedies, be sold by way of derogation from the provision on the

State in Chapter 2. section 1 of the new law until

december 31, 2009.



2013:38



1. this law shall enter into force on 1 January 2013.



2. a person who conveys human use on 1 January 2013 shall notify

its activities under 3 (a). section 1 of the National Agency for medicines

last modified on May 2, 2013.



2016:133



The Government states that the Act (2013:39) amending the Act (2009:366) on trade in drugs shall enter into force on 12 april 2016. The provisions on security details shall apply 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.