Regulation (2013:80) If The Contribution To The Outpatient Pharmacy Service Of General Economic Interest

Original Language Title: Förordning (2013:80) om bidrag till öppenvårdsapoteksservice av allmänt ekonomiskt intresse

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Read the untranslated law here: http://rkrattsbaser.gov.se/sfst?bet=2013:80

Introductory provision



paragraph 1 of this regulation are regulations on State aid to

some establishments for retail trade in medicinal products conducted

licensed under Chapter 2. section 1 of the Act (2009:366)

with drugs.



The goal of the State's contribution is to maintain good

supplies of drugs throughout the country.



The person who is entitled to compensation under this regulation

shall be deemed to have completed the outpatient pharmacy service of General

economic interest.



Definitions



paragraph 2 of this regulation the following definitions shall

below the specified importance.



Outpatient pharmacy facility for retail

medicine is conducted with permission

According to Chapter 2. section 1 of the Act (2009:366) about

trade in medicinal products.



The licensee of the one for a certain community pharmacies

permitted according to Chapter 2. 1 §

Act (2009:366) on trade in

medicines.



Unit-dose packed drugs all non medicines

for people, who are covered by the

öppenvårdsapotekets State and that

is prescribed on the prescription.



Distance selling An outpatient pharmacy retail

medicines to consumers who do not receive

access to the medicine in the pharmacy's

premises.



Premium years The years immediately following the

calendar year in which the application for a grant

refers to.



Conditions for State aid



paragraph 3 of the Contribution is provided, subject to availability of funds. A

licence holders may apply for grants for the

community pharmacies the authorization relates. Application may not relate to

contributions for the time when someone other than the applicant,

licence holders.



4 § Contributions may only be made to an outpatient pharmacy

during the calendar year preceding the grant year



1. be located more than twenty kilometers from another

community pharmacies,



2. had its premises open so that consumers could get

access to medicines for all calendar months, and



3. had sales revenue of medicines amounted to

at least a million dollars but not more than ten million.



section 5 For an outpatient pharmacy that does not satisfy the requirement in paragraph 4 of the

2, the amounts referred to in paragraph 4 of 3 rather than be determined in

relation to the number of calendar months which the Pharmacy has

been open.



Contributions may be made to an outpatient pharmacy whose

sales revenue is within the range defined

as indicated in the first subparagraph if the pharmacy also meets

the other conditions of grant.



section 6 of the assessment of whether the condition in section 4(1) are complied with shall be made

on the basis of the situation as at 1 January

the calendar year immediately preceding the grant year.



For an outpatient pharmacy that has nyetablerats in

calendar year applies instead of the date referred to in

the first paragraph, the date of the consumers for the first time.

could get access to drugs inside the öppenvårdsapotekets

premises.



In the calculation of sales revenue under this regulation

sale by mail order of medicinal products should not be included.



section 7 For an outpatient pharmacy that meets the requirements of section 4 and

the sales revenue of the drug did not exceed two

million also applies, for the right to grant, to

Apoteket's premises should have been open for consumers during the

an average of at least 14 hours per week.



For an outpatient pharmacy that meets the requirements of section 4 and whose

sales of medicines exceeded two million

SEK also applies, for the right to grant, to the pharmacy's

premises should have been open to consumers for an average

at least 30 hours per week.



The first and second subparagraphs shall also apply to a

community pharmacies that do not meet the requirement of paragraph 2, however,

the amounts referred to in the first and second subparagraphs instead

be determined in relation to the number of calendar months

the Pharmacy has been open.



section 8 Subsidies must not be provided to a licensee that has

liabilities for Swedish taxes or fees in

Enforcement authority or which are in liquidation or

bankrupt. Contributions must not be made if

the State of the community pharmacies applied for has

been revoked at the time of the decision on the contribution.



Calculation of the amount of the grant



9 § support under this Regulation shall be in accordance with

The European Commission's decision 21/EU of 20 december

2011 on the application of article 106(2) of the Treaty on

The functioning of the European Union on State aid in the form of

public service compensation granted to certain

undertakings entrusted with the operation of services of

General economic interest.



section 10 of the amount shall be determined in relation to how

many calendar months of the calendar year in which it has been conducted

sales of drugs to consumers in

öppenvårdsapotekets premises.



Application



section 11 of the application for a grant shall be made in writing to the

Dental and pharmaceutical benefits Board.



The application shall be signed by

the holder of the authorization. The information contained in the application shall be submitted to the honours

and conscience.



section 12 of the application for funding must be submitted to the dental

and pharmaceutical benefits agency by 1 March of the grant year.



section 13 A licence holders applying for grants under this

Regulation should provide dental and pharmaceutical benefits agency

the documents and information necessary to

be able to examine the application.



section 14 If a licensee does not submit the documents or

functions required by section 13, shall be given an opportunity to

within certain time supplement the application. Follow a holder

not prompted to complete an application, this

be examined as is.



Determining authority, etc.



section 15 dental and pharmaceutical benefits work examines the contribution

According to this regulation.



Decision on the contribution to be made by only one point each

Premium years.



Documentation and reporting



section 16 of a beneficiary is obliged, upon request of

Dental and pharmaceutical benefits work leave it basis

necessary for Sweden to fulfil such obligations

resulting from the Commission's decision 21/EU.



section 17 of the dental and pharmaceutical benefits the work should last 1

March of each year, beginning in 2015, leaving an overall economic

report of the previous year's decisions to

the Government. The report shall indicate



1. What are the licence holders who have received grants and which

outpatient pharmacy spending concerns and how many applications for

contribution has been rejected,



2. what changes in opening hours that has occurred for the

outpatient pharmacy that received funding in the past year, and



3. a forecast for the coming bidragsårets grant.



Dental and pharmaceutical benefits work, even by 1

June every two years submit a summary of

use and effects of State contribution in relation to the

objectives referred to in paragraph 1, second subparagraph.



Refunds and chargebacks



18 § a beneficiary is obliged to refund if



1. the receiver by providing incorrect information or

otherwise have caused that contributions have been made incorrectly

or with excessive amounts,



2. the grant of any other reasons have been given incorrectly, or

with the high amount and the recipient should have known this,

or



3. the recipient has not provided such a basis referred to in 16

§.



19(8) If a beneficiary is required to repay pursuant to the

section 18, dental and pharmaceutical benefits administration may decide to

completely or partially recover the premium. If there is

specific reasons, dental and pharmaceutical benefits agency

remit the claim for repayment in whole or in part.



Appeal



section 20 of the dental and pharmaceutical benefits Board's decision pursuant to

This Regulation shall not be subject to appeal.



Authorization



paragraph 21 of the dental and pharmaceutical benefits agency must notify



1. additional regulations on how Government grant will

is calculated, and



2. the regulations on the enforcement of this regulation.



Transitional provisions



2013:80



1. this Regulation shall enter into force on 1 april 2013 and shall

apply from 1 January 2013 in terms of contribution

relating to the calendar year preceding the grant year 2014.



2. For the grant year 2014, apply to contributions that relate to a

community pharmacies may not relate to the time when the licensee on

because of agreements with the State had a duty to drive

öppenvårdsapoteket.



3. Dental and pharmaceutical benefits Board's first

Summary of State grant use and

effects in relation to the objectives set out in article 1, other

subparagraph shall be submitted to the Government last March 1, 2016.