Regulation (2009:659) On Trade In Pharmaceuticals

Original Language Title: Förordning (2009:659) om handel med läkemedel

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Read the untranslated law here: http://rkrattsbaser.gov.se/sfst?bet=2009:659

Introductory provision



1 §/expires U: 2016-01-01/

This regulation prescribes that connects to

Act (2009:366) on trade in drugs. The terms and

terms used in this Act have the same meaning in this

Regulation.



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

This regulation prescribes that connects to

Act (2009:366) on trade in drugs. The terms and

terms used in the Act have the same meaning in this

Regulation. Regulation (2015:462).



Authorisation decision



section 2 of an authorisation decision pursuant to Chapter 2. section 1, Chapter 3. 1 §

or Chapter 6. section 1 of the Act (2009:366) on trade in medicinal products,

be notified within 90 days from the date the application is complete.



Fees



section 3, an applicant for a permit to conduct the retail sale of

medicines to consumers pursuant to Chapter 2. section 1 of the Act (2009:366)

If the trade in medicinal products must pay a filing fee with

20 000 SEK per State.



The holder of a licence referred to in the first subparagraph shall

pay an annual fee, with 11 500 kr per State. For a

outpatient pharmacy where manufacture of medicines for certain

opportunity is conducted, shall, in addition, an annual fee of

5 500 SEK is paid. Regulation (2013:52).



3 a of the applicant for a permit to conduct retail

with drugs to consumers pursuant to Chapter 2. section 1 of the Act

(2009:366) on trade in medicinal products must pay a fee of

$200 for the issue of a certificate showing that the applicant has

conditions to meet the requirements provided for in Chapter 2.

6 § 5-7 the same law.



The holder of a licence referred to in the first subparagraph shall

pay a fee of $500 for the control of the electronic

system for direct access to data in

E-hälsomyndigheten which the holder of the authorization shall be in accordance with Chapter 2.

6 § 6 law on trade in drugs. Regulation (2013:1041).



4 § the applicant for permission to engage in activity as a wholesaler in

medicinal products as defined in Chapter 3. section 1 of the Act (2009:366) on trade in

agents should pay the application fee by 40 000 SEK per

State.



The holder of a licence referred to in the first subparagraph shall

pay the annual fee with 13 500 SEK per State.



§ 5 the applicant for a permit to conduct mechanical

single dose distribution at community pharmacies in accordance with Chapter 6. section 1 of the Act

(2009:366) on trade in pharmaceuticals will pay

application fee of $25,000 per State.



The holder of a licence referred to in the first subparagraph shall

pay the annual fee of 17,000 USD per State.



section 6 of the hospital pharmacy in accordance with Chapter 5. section 1 of the Act

(2009:366) on trade in medicinal products must pay the annual fee with



1.15 500 SEK for activities involving the manufacture of

medicines for a particular occasion,



2. $1,000 for activities that do not involve manufacturing

of medicines for a particular occasion.



section 7 fees under § 3 and § 4-6 shall be paid to the

The medical products agency. Charges under section 3 (a) shall be paid to the

Email hälsomyndigheten. Regulation (2013:1041).



section 8 Additional regulations on fees, see

fee Regulation (1992:191).



Supply of medicines, etc.



§ 9/expires U: 2016-01-01/

Anyone who has permission to conduct the retail sale of

medicinal products as defined in Chapter 2. section 1 of the Act (2009:366) on trade in

agents should provide the products and goods referred

in Chapter 2. 6 § 3 of the same law as soon as it can be done.



If the medicinal product or the goods are not on öppenvårdsapoteket,

should provision be made within 24 hours of the

the consumer requested the drug or product, with the exception

for if



1. the product or the product is not available for order with

supplier,



2. consumer demand for the drug at a time

means that the delivery cannot take place for öppenvårdsapoteket

within 24 hours,



3. it's a long distance to öppenvårdsapoteket,



4. öppenvårdsapoteket is not opening the next day,



5. it is a medicine



(a)) that the first subparagraph of paragraph 5 of the medicines Act (1992:859)

can be sold without authorization, registration or recognition of

an authorisation or registration, or



(b)) for which the authorisation of the sale submitted pursuant to paragraph 5 of the

the third paragraph of the medicines Act, or



6. There are other noteworthy reasons.



The situations referred to in the second subparagraph 1 – 6 may

the time limit referred to in the second subparagraph shall not be exceeded by more than

What is necessary for the medicinal product or the goods must

able to be provided. Regulation (2014:467).



§ 9/entry into force: 01/01/2016

Anyone who has permission to conduct the retail sale of

medicinal products as defined in Chapter 2. section 1 of the Act (2009:366) on trade in

agents should provide the products and goods referred

in Chapter 2. 6 § 3 of the same law as soon as it can be done.



If the medicinal product or the goods are not on öppenvårdsapoteket,

should provision be made within 24 hours of the

the consumer requested the drug or product, with the exception

for if



1. the product or the product is not available for order with

supplier,



2. consumer demand for the drug at a time

means that the delivery cannot take place for öppenvårdsapoteket

within 24 hours,



3. it's a long distance to öppenvårdsapoteket,



4. öppenvårdsapoteket is not opening the next day,



5. it is a medicine



(a)) according to Chapter 5. the third subparagraph of paragraph 1 of the medicines Act

(2015:315) can be sold without authorization, registration or

recognition of an authorisation or a registration for

sale, or



(b)) are subject to authorisation of the sale pursuant to Chapter 4. 10 §

second subparagraph, the medicines Act, or



6. There are other noteworthy reasons.



The situations referred to in the second subparagraph 1 – 6 may

the time limit referred to in the second subparagraph shall not be exceeded by more than

What is necessary for the medicinal product or the goods must

able to be provided. Regulation (2015:462).



10 § whoever has permission to engage in activity as a wholesaler in

medicinal products as defined in Chapter 3. section 1 of the Act (2009:366) on trade in

medicinal products shall deliver the products covered by the

the State of community pharmacies as soon as it can be done.



Whistleblowing schemes



section 11 to E-hälsomyndigheten will be able to keep statistics

According to Chapter 2. section 6 of the 7 teams (2009:366) on trade in pharmaceuticals,

for the person who has permission to conduct the retail sale of

medicinal products as defined in Chapter 2. paragraph 1 of the same law each month leave

information to the Agency about the medicines sold

the previous month.



The data shall include information on



1. name of the medicinal product,



2. pharmaceutical form,



3. strength,



4. pack size,



5. number of packages,



6. the date of sale,



7. the selling price and, where appropriate,

cost reduction pursuant to lagen (2002:160) if

pharmaceutical benefits, etc.



In the case of distance sales, and in addition to the information specified in

the second paragraph, the customer's item number is specified.



The information referred to in the second and third paragraphs shall

prices are per sales transaction separately for each

one of the outpatient pharmacy for which the permit is valid.



The second and third subparagraphs shall not apply to such information

already provided to the Pharmacy Service limited company or

E-hälsomyndigheten in accordance with the Act (1996:1156) on

prescription records. Regulation (2013:1041).



section 12 to E-hälsomyndigheten will be able to keep statistics

According to Chapter 3. 3 § 2 and Chapter 4. section 2 of the Act (2009:366)

with drugs, the who has permission to conduct

wholesale distribution of medicinal products as referred to in Chapter 3. section 1 and the

permission to engage in retail trade in medicinal products as

Chapter 4. paragraph 1 of the same law, each month send information to

authority of the medicines 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. number of packages,



6. the date of sale,



7. selling price,



8. to any natural or legal person the sale has

occurred.



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

sales transaction.



The first paragraph does not apply to sales transactions

between operators who are licensed pursuant to Chapter 3. paragraph 1 of the law on

trade in medicinal products. Regulation (2013:1041).



paragraph 13 of the information referred to in paragraphs 11 and 12 shall be

E-hälsomyndigheten to happen within seven days from the

last day of the month following the month in which

accounts cover. The data to be transferred

electronically. Regulation (2013:1041).



Register of intermediaries of medicinal products for human use



13 a of the Agency shall keep a register of intermediaries

which notified their operations under 3 (a). Article 1, first paragraph

Act (2009:366) on trade in drugs. The medical products agency

to unregister the intermediaries that do not meet the requirements

set of 3 a Cape. paragraph 2 of the same law. Regulation (2013:21).



Supervision report



13 (b) § When the FDA has conducted an inspection visit to the

a wholesale distributors or intermediaries of medicinal products for human use, a

report of the inspection. In the report to the work

account the inspected follow good distribution practice

in accordance with European Union legislation, as

applicable, on the one hand, the other requirements of the business.



Within 90 days of an inspection as referred to in

the first paragraph has been completed, the work will draw up a certificate

for the good inspected in accordance with the applicable practice

Union law, if it has come out from under the

inspection shows that the inspected follows such practice.

Regulation (2013:21).



Appropriations



section 14 of the food and Drug Administration may provide for



1. the design of such premises as described in Chapter 2. 6 § 2


and Chapter 3. 3 § 1 Act (2009:366) on trade in pharmaceuticals

as well as on the use of the trade mark as referred to in Chapter 2. 6 §

12 the same law,



2. what skills and experience in a pharmaceutical Manager who

are not pharmacists should have,



3. own the control according to Chapter 2. 6 section 8, Chapter 3. section 3, 5, and 3 a

Cape. 2 § 3 law on trade in pharmaceuticals,



4. What documentation is required under Chapter 3. 3 § 3 and 3 (a)

Cape. 2 § 2 the law on trade in pharmaceuticals,



5. what skills and experience as an expert according to

Chapter 3. paragraph 3 of the 4 drug trading act shall have,



6. how the notification requirement under 3 (a). § 1 and Chapter 5.

2 and 3 of the law on trafficking in drugs is to be performed,



7. good distribution practice in other respects in accordance with Chapter 3. 3 § 12 and 3 a

Cape. 2 § 5 Act on trade in pharmaceuticals,



8. the design and control of the COMMUNITY logo referred to in 2

Cape. 10 (a), paragraph 2 the law on trade in medicinal products, and



9. trade in medicines that are needed to protect human

and animal life or health, as well as for the environment.

Regulation (2015:201).



Enforcement regulations



section 15 of the MPA may announce further provisions concerning

Court-tions of the law (2009:366) on trade in pharmaceuticals

and by this regulation.



Transitional provisions



2009:659



This Regulation shall enter into force on 1 July 2009, when the

Regulation (1996:1290) on trade in drugs, etc.,

cease to apply. Older regulations, however, still

for order issued before the entry into force.