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.
