Introductory provision
paragraph 1 of this regulation are regulations that connect to
Act (2002:160) on drug benefits, etc., The terms and
terms used in this Act have the same meaning in this
Regulation.
What is being said about the counties in this regulation also applies
municipalities that are not part of a County.
Regulation (2009:633).
Restrictions on pharmaceutical benefits
section 2 of the Drug benefits under section 5 of the Act (2002:160) if
pharmaceutical benefits accommodation and cost of freedom according to section 19 of the same
teams may not refer to a greater variety of drugs or products other than
that corresponds to the estimated need for 90 days or, if
appropriate presentation for 90 days are missing, immediately above
packaging. However, this does not apply to goods referred to in section 18 1
that law.
A medicinal product or another product that is prescribed shall not
be prescribed again as long as the prescription is still
valid, if the aim is only to get the medicine or product
delivered on more favourable terms.
If there are special reasons may be pharmaceutical benefits relate to a
a greater variety of drugs and goods other than what is stated in the first
paragraph. Regulation (2006:1118).
section 3, a new one-year period referred to in paragraph 5 of the Act (2002:160) if
pharmaceutical benefits etc. cannot begin until the previous
period of one year has gone to the right, subject to paragraph 3 (a)
This regulation. Regulation (2006:1118).
3 a § of the quantity of medicines or other goods are despatched
refers to a larger amount than what is said in paragraph 2 of the first paragraph,
shall the medicines and other goods intended for
meet time after the one year period referred to in paragraph 5 of the
second subparagraph, Act (2002:160) on drug benefits, etc.
is estimated to have expired, subject to a cost reduction.
Cost reduction shall be calculated on a new such
a one-year period, counted from the first day after the previous
the one-year period is estimated to have expired. Regulation (2006:1118).
Workplace code
4 § everyone who has a job and is qualified to prescribe
medicinal products or goods referred to in section 18 (2) and (3) the law
(2002:160) on drug benefits, etc. are entitled to receive a
workplace code.
The County Council may otherwise decide on design and distribution
of workplace code for those who have their place of work within
the County Council's area.
If the County finds that the applicant is not entitled to
workplace code, the matter shall be submitted to the National Board of health and welfare
for the examination.
A workplace code only applies as long as the conditions in
the first subparagraph are fulfilled. Regulation (2006:1118).
Determination of the purchase and sales price
4 a of the dental and pharmaceutical benefits agency must notify
regulations on how the purchase price and sales price in
section 7 of the Act (2002:160) on drug benefits, etc.,
be determined. Regulation (2009:633).
4 b of the dental and pharmaceutical benefits agency must notify
regulations on the conditions for modification of the purchase price and
selling price for a drug that is included in the
pharmaceutical benefits if it
1. have gone 15 years after the drug is approved for
sale, or
2. are medicinal products that are interchangeable with the drug and that
marketed to community pharmacies in Sweden.
Regulation (2014:466).
Non-prescription medicines
paragraph 5 of the dental and pharmaceutical benefits agency must notify
regulations on conditions for a given prescription
drugs or a specific group of such medicinal products should be included in the
pharmaceutical benefits. Regulation (2008:656).
Products other than drugs
section 6 of The reduction of the price of certain foodstuffs provided for
in section 20 of the Act (2002:160) on pharmaceutical benefits accommodation applies when
a child suffers from any of the diseases listed in the annex
to this regulation.
Agency shall draw up a list of
foods covered by the price reduction. The work shall also
specify the specialized expertise required for doctors
shall have the authority to prescribe such foods.
paragraph 7 of such a prescription of foodstuffs referred to in section 20 of the Act
(2002:160) on drug benefits, etc., shall be made on the
food instruction.
Food instruction shall specify how many times
the prescription may be dispensed. Prescribing, for each
expedition refer to a maximum of the amount of food that corresponds to the
estimated need for 90 days.
section 8 A prescription of supplies as referred to in section 18 (2)
and 3 the law (2002:160) on drug benefits, etc., and in 3 d
and 18 c § § health care Act (1982:763) shall be made at
a ease of access cards.
In the accessibility card shall specify such a workplace code
referred to in paragraph 4. It shall be stated how many times
the prescription may be dispensed. Regulation (2006:1118).
Handling, etc.
§ 9 dental and pharmaceutical benefits agency must issue a decision
within 180 days from the time a complete application for a
medicine or an article should be included in drug benefits came in
to the authority.
A decision to increase the amount of a previously established
the sales price must be notified within 90 days of
the application came in to the Office. If the information provided
in support of the application is inadequate, the authority shall, as soon as
inform the applicant of the additional information required
and take its decision within 90 days after
additional information received. If the number of applications is
very large, may the deadline be extended only once with
an additional 60 days. The applicant shall be informed of such
extension before the deadline expired.
In the absence of such a decision within the time or times specified
in the second subparagraph, the applicant has the right to execute the requested
the price increase to the full.
A decision on the reduction of a previously established
the sales price must be notified as soon as possible.
Regulation (2008:656).
section 10 of the dental and pharmaceutical benefits agency shall publish
a list of the products included in the
drug benefits as well as information on the prices that may be
out of these products. This list and these data
at least once a year, be referred to the European
the Commission. Regulation (2010:1381).
Validity of prescriptions, etc.
section 11 of The prescription by prescription is valid one year from
issuance unless the prescriber indicates shorter period of validity.
It should be clear by prescribing how many times it gets
dispensed.
Prescriptions referred to in paragraphs 7 and 8 are valid one year from
issue.
At every expedition to öppenvårdsapotekets name and date
for the expedition set out on the prescription. In order for the goods to be
the scope of drug benefits under section 5 of the Act (2002:160) if
drug benefits, etc. or free according to § 19
the same law, the prescription is dispensed at the new first then
at least two-thirds of the time lapse of the previous
expedited the amount of medicines or other products intended to
cater. The prescription may be dispensed prior to
If there are special reasons for this.
At the expedition of a prescription to a voucher
be drawn up of the disclosure. The voucher must contain
information on prescribed and what is disclosed.
Öppenvårdsapoteket retains the prescription unless the
the customer requests that it should be left to him. Prescription
or a copy of this form öppenvårdsapotekets
voucher. Regulation (2009:633).
The exchange of drugs
section 2 of the dental and pharmaceutical benefits agency must notify
provisions on the exchange of drugs under section 21 of the Act
(2002:160) on drug benefits, etc.
In the case of when a pharmacist may oppose replacement according to
21 paragraph 2 Act (2002:160) on pharmaceutical benefits
accommodation, however, instead the FDA regulate
After giving the dental and pharmaceutical benefits agency
opportunity to be heard. Regulation (2014:466).
Penalties and fines
12 a of The penalty that may be imposed under section 25 law
(2002:160) on drug benefits, etc. shall be determined for
not less than five thousand dollars and not more than SEK 10 million.
Regulation (2014:466).
Disclosure from community pharmacies
section 13 medicines and other goods covered by the Act (2002:160) on drug benefits, etc., in cases of urgency, be disclosed even though the prescription has not been made on the prescribed form. In such a case, the prescribing attest to it are an urgent case and provide the information that would have been provided if the prescribed form had been used.
A supply referred to in this paragraph may be dispensed only once. Öppenvårdsapoteket to keep the plot as their voucher or document data and maintain these as their voucher. Regulation (2015:974).
section 14 by the expedition of a prescription that is retained by
öppenvårdsapoteket, if the customer requests it,
öppenvårdsapoteket leave him a copy of the document. On
This Act shall not apply to the expedition.
Regulation (2009:633).
section 15 on each occasion, the expedition öppenvårdsapoteket
provide a special receipt for the amount that the customer
paid for the products covered by the pharmaceutical benefits.
Öppenvårdsapoteket shall take the other measures
needed for the customer to get drug benefits.
Regulation (2009:633).
Öppenvårdsapotekets right to compensation
section 16 Have medicines or other goods referred to in the law
(2002:160) on drug benefits, etc. disclosed
free of charge or with cost reduction from
öppenvårdsapoteket for the prescription, have öppenvårdsapoteket
entitled to reimbursement of the county councils referred to in section 22
the same law with an amount equal to the sales price
each of the prescribed cost reduction.
Compensation to be paid retrospectively, with compensation to be found
to a particular month must be paid on the first working day which is not
Saturday, in the second month after that. Compensation shall be paid
to E-hälsomyndigheten that conveys it to
the community pharmacies. In addition, compensation is paid on the
way the county councils, E-hälsomyndigheten and öppenvårdsapoteket
will agree. Regulation (2013:1036).
Vouchers
section 17 of the documents referred to in this regulation constitutes
öppenvårdsapotekets supporting documents must be kept for three years from
the day öppenvårdsapoteket demanded compensation for them.
The supporting documents shall be submitted, at the request of a County
to the County Council for review. Regulation (2009:633).
section 18 of the County Council may review claims under section 16 of the
and make sure that medicines and other goods released
free of charge or at reduced cost, subject to the law
(2002:160) on drug benefits, etc.
Determination of forms
section 19 of the MPA shall, after consultation with the dental and
the pharmaceutical benefits Board and the county councils, establish forms
referred to in paragraphs 7 and 8. Regulation (2008:656).
Appeal
section 20 of the 22 a of the Administrative Procedure Act (1986:223) contains provisions
If an appeal to the administrative court.
Additional regulations
paragraph 21 of the dental and pharmaceutical benefits administration may announce further provisions on the enforcement of the law (2002:160) on pharmaceutical benefits accommodation and welfare may provide for workplace codes as well as the enforcement of section 18 (2) and (3) the same law.
Regulation (2015:974).
Transitional provisions
2002:765
This Regulation shall enter into force on 15 november 2002 but
apply for the period from 1 October 2002. Decision on
sales prices for non-prescription medicines
Insurance Administration has taken under the Act (1996:1150) on
high-price protection on medicines, etc. still apply.
2014:466
This Regulation shall enter into force on the 1 January 2015 in respect of
section 12 of and otherwise on 1 July 2014.
Annex
List of diseases eligible for
price reduction of food pursuant to section 20 of the Act (2002:160) if
pharmaceutical benefits, etc.
Chron's disease
Phenylketonuria
Galactosemia
Gluten intolerance
Komjölksproteinintolerans
Short small intestine
Lactose intolerance (congenital and secondary)
Chronic renal insufficiency
Soy protein intolerance
Ulcerative colitis
