1

PROPOSED LAW NO. 124 /X

Exhibition of Motives

1. The current legal regime of the workshop pharmacies essentially dates back to the decade

of 60 from the last century.

The evolution of society, the dynamism of pharmacies and the profound changes in the

drug sector advises a legislative reform.

2. On the other hand, the legislation setting out the framework of this activity was

approved in a national and European context without parallel in the topicality, so

matter to adapt it to the new reality of Portuguese society.

3. Pretend to modify a disappropriate and unjustifiably legal regime

restrictor of access to property, sidelining the rules that restrict it

exclusively to pharmacists.

The removal of these restrictive rules considered the developments verified in the Union

European and, at the same time, the national reality.

It is intended to balance free access to property and avoid concentration, through

of a limitation, proportional and appropriate, to four pharmacies.

To this title it is important to mention that the property of pharmacies is intended to

stay reserved for natural persons and commercial companies, enabling,

consequently, a tight administrative control of the respective title.

Attending to the particularities of the sector and to saluting competition between pharmacies, the

new legislation will strengthen the regime of incompatibilities in relation to property,

exploitation and management of pharmacies, either directly or indirectly.

The scheme will be characterised by transparency and thoroughness with regard to the

legal business on the entitlement of pharmacies, cominating with nullity

those who are celebrated against the rules instituted or which produce an effect

practical identical to what the law wanted to ban.

4. The sanctionatory provisions constitute an important modification of the

relationship of pharmacies with the state, translated in the absence of any

specific crime.

2

This is not a real decriminalization, but only recognition

of the sufficiency of the prevailing criminal legislation in the prediction of the types of illicit with

criminal relevance integrators of ducts arising from violation of norms

legal.

At the same time, the new regime provides for a panoply of illicit of mere ordering

social, applicable to natural and legal persons, who express the idea of

warning and social censorship, through which the Administration affirms the will of

protect the public interest and assume the competence of the respective application.

Being subject matter for the relative reserve of legislative competence, it has chosen to propose

a proposal for a permit law, taking into consideration the technical specificity

of the legal regime of the workshop pharmacies.

Thus:

Under the terms of the paragraph d) of Article 197 (1) of the Constitution, the Government presents to the

Assembly of the Republic the following proposal for a law:

Article 1.

Subject

The Government is granted permission to approve the legal regime of pharmacies of

workshop and adapt the general regime of counter-ordinations to the offences committed in the

exercise of pharmaceutical activity.

Article 2.

Sense

The present legislative authorization is granted to allow the conditions of

access to the property of workshop pharmacies, set limits on the number of

pharmacies held and to the possibility of transactioning the respective licences, proceed to

increase in the number of incompatibility situations that determine the prohibition of

natural or legal persons to be the owner of pharmacies, eliminate the

criminal offences contained in the previous legal regime on the property of pharmacy,

as well as enshrine a maximum amount of fine applicable to the offences

committed in the exercise of the pharmaceutical activity higher than that provided for in the general scheme

3

of the counter-ordinations.

Article 3.

Extension

The decree-law to be adopted under the authorisation conferred by this Law shall

establish the:

a) Alteration of the property of the pharmacy, in the sense of allowing all the

natural persons or commercial companies may be the owner of

pharmacies;

b) Change to the maximum number of pharmacies per owner, from one to

four;

c) Alteration of incompatibilities with the property of the pharmacy, forbidding

the detention and the exercise, direct or indirect, of the property, of the holding

or from the management of pharmacies to:

i) Health professionals prescribers of medicinal products;

ii) Representative associations of pharmacies, distribution companies

wholesale of drugs or companies in the pharmaceutical industry, or

of the respective employees;

iii) Wholesale distribution companies of medicines;

iv) Companies in the pharmaceutical industry;

v) Private companies providers of health care;

vi) Subsystems that participate in the price of medications.

d) Impossibility for pharmacies to be sold, trespassed or leased

or the respective farm being ceded before decorating five years to count

of the day of the respective opening;

e) Revocation of the deontological standards provided for in Law No. 2125, 20 of

March 1965, and in the Decree-Law No. 48547 of August 27, 1968;

f) Elimination of criminal wrongs provided for in Law No 2125 of March 20 of

1965, and in the Decree-Law No. 48547 of August 27, 1968;

g) Fixing the maximum amount of the fines corresponding to the illicit of mere

social ordinance, for violation of the legal provisions of the legal regime of the

workshop pharmacies, in the amount of € 20,000 in the case of the offender being a person

singular, and in the amount of € 50,000 in the situations in which the offender is a

4

legal person.

Article 4.

Duration

The legislative authorization granted by this Law shall be for the duration of 180 days.

Seen and approved in Council of Ministers of March 1, 2007

The Prime Minister

The Minister of the Presidency

The Minister of Parliamentary Affairs

5

The legal regime of the workshop pharmacies, defined in the present decree-law, establishes

a global and framing framework of the sector.

The present legislative intervention allows for the legal reorganization of the sector of

pharmacies, whose regime essentially dates back to the 60 of the last century.

The evolution of society, the dynamism of pharmacies and the profound changes in the

drug sector advises this legislative reform.

On the other hand, the legislation that now repeals itself has been passed in a national context and

unparallelable in the topicality, so it matters to adapt it to the new reality of the

Portuguese society.

1. This reform modifies a disappropriate and unjustifiably legal regime

restrictor of access to property, sidelining the rules that restricted it

exclusively to pharmacists.

The removal of these restrictive rules considered the developments verified in the Union

European and, at the same time, the national reality.

It is intended to balance free access to property and avoid concentration, through

of a limitation, proportional and appropriate, to four pharmacies.

To this title it is important to mention that the property of the pharmacies is reserved to

natural persons and commercial companies, enabling, consequently,

a tight administrative control of the respective title.

Attending to the particularities of the sector and to saluting competition between pharmacies,

this decree-law reinforces the regime of incompatibilities in relation to the property,

exploitation and management of pharmacies, either directly or indirectly.

2. Merece, likewise, highlight the established framework for the legal status of the

owners of pharmacies.

In fact, with the present decree-law imposes the change of the ownership of the

pharmacies that are currently held, specifically, by private institutions

of social solidarity. In the future, these will have to constitute commercial societies,

in order to ensure tax equality with the remaining pharmacies.

3. On the other hand, it should be pointed out that the previous legislation has fostered, over time,

the creation of fictitious situations in relation to the property, by virtue of a regime

extraordinarily restrictive of the transmission of the property between pharmacists.

With the amendment of the legal regime of the property will allow for regularisation

of these situations, provided that they observe the requirements and limits of entitlement and

respect incompatibilities in relation to the ownership, exploitation and management of

6

pharmacies.

Thus, this new regime is characterised by transparency and thoroughness in what

respects the legal business on the entitlement of pharmacies, comining with

the nullity those who are concluded against the rules now instituted or who

produce a practical effect identical to what the diploma wanted to ban.

4. In the systematic of the present diploma underscore the regulation of the technical direction of the

pharmacy. The vital importance of this matter, in the reorganisation of the sector, stands out

for two main reasons.

First, the unsurmountable requirement for the technical direction to be ensured,

in permanence and exclusivity, by a pharmacist subject to rules

deontological own and demanding, in order to guarantee and promote quality and

continuous improvement of services provided to users.

Second, the autonomy of the role of the technical director gains relief,

listening to the dissociation between pharmacy property and title by

pharmacist. Thus, precise duties are imposed, objectiable to the

owner, whose control may also be carried out by the Order of the

Pharmaceuticals, in the context of the valorisation of the deontological rules.

It is emphasized that the legal binding of the technical director to the fulfilment of the

general provisions of this decree-law, specifically the promotion of use

rational of the medicinal product, the duties of collaboration and pharmacovigilance, reflects

the public interest that characterizes the activity of dispensing medicines.

5. It also deserves a special highlight the change in the standards concerning the framework of

staff of pharmacies, in obedience to an idea of progressive qualification.

It is now established as a rule that the pharmacy possesses a majority of

pharmacists. At the same time, an exception is allowed, concerning the processing of

pharmaceutical posts in pharmacies, in order to enable the adaptability of the

respective frame.

This requirement is directly related to two concrete aspects of the scheme

legal of the sector.

On the one hand, the obligation of the technical director to be at the on-call pharmacy and

exclusivity presupposes the indication of a pharmacist who replaces it in his

absences and impediments, specifically in the holidays, so the pharmacy has to

have at least two pharmacists.

On the other hand, the working hours of pharmacies presupposes permanence

7

of at least one pharmacist 55 hours a week, which will only be possible with

a minimum frame of two pharmacists.

6. It is also to be pointed out that the present diploma continues to provide for the award of

new pharmacies through public tender.

The regulation of the licensing will be the subject of a diploma of its own, in which they will adapt

the rules of capitation and distance to the needs of users in accessibility to the

medication.

The requirements of the licensing will also be modified, depending on the

subjective change in the ownership of pharmacy and the promotion of fair sharing and

equitable of alvarás, based on the smallest entitlement of establishments by

competitor, within the limit of four pharmacies.

The new regime evidences the possibility of transfer of pharmacies within the

same municipality, regardless of pudic and licensing contest, in

elapsed from the principle of freedom of installation.

7. This decree-law does not alter the list of products to be provided to the public by pharmacies,

only clarifies and updates the terminology used.

With respect to the dispensation of medicinal products, the new legal regime allows the

pharmacies-and, in the case of medicines not subject to prescription, also to the

places of sale of these medications-dispensing us through the Internet and to the

Household.

These new forms of relationship of pharmacies with users were

thoughtful, especially, for situations of people unable to get there if

displace.

Pese although the genesis of these innovative dispensation possibilities, has not been predicted

any restriction on the collection of an additional value for the provision of these services.

Still in what concerne the products on sale in the pharmacies, opens the possibility

of these to acquire medicinal products through concourse, situation expressly

prohibited in the repealed legislation and which, for reasons of consistency, does not find

any reflection in the new legislation.

8. In this decree-law, it assumes a particular relevance to the possibility of pharmacies

to provide pharmaceutical services, the definition of which will fit the Government.

Therefore, it is allowed that pharmacies, on a par with the dispensation of medicinal products,

perform other duties of relevant public interest in promoting health and

of the well-being of users.

8

9. It is patent, along the decree-law, the concern for the quality of services

provided by the pharmacies, considering that it is an activity whose

public interest assumes the greatest relevance that justifies express forecast

legislative.

To ensure the effective and effective follow-up of irregular situations,

specifically contrary to the legally instituted or deficient standards

provision of services, as well as deontological offences, the decree-law institutes

obligation for pharmacies to have complaints books.

As for this matter, the new decree-law adds an embossing innovation, to the

to establish the possibility for users to claim in a given area of a

site in the Internet , specific to these situations.

10. The sanctionatory provisions constitute an important modification of the

relationship of pharmacies with the state, translated in the absence of any

specific crime.

This is not a real decriminalization, but only recognition

of the sufficiency of the prevailing criminal legislation in the prediction of the types of illicit with

criminal relevance integrators of ducts arising from the violation of this decree-

law.

At the same time, the new regime provides for a panoply of illicit of mere ordering

social, applicable to natural and legal persons, who express the idea of

warning and social censorship, through which the Administration affirms the will of

protect the public interest and assume the competence of the respective application.

11. Another aspect to be highlighted in this diploma translates into the collaboration between INFARMED

and the Order of Pharmacists in the supervision of infringements of the legislation, assuming

the administrative entity the duty to communicate to that Public Association the

behaviors that do not conform to the rules of a deontological nature.

They were heard, on an optional basis, the Order of Pharmacists, the National Association

of the Pharmacies, the Association of Pharmacies of Portugal, the Portuguese Association of the

Graduates in Pharmacy and the National Syndicate of Pharmacists.

Thus:

In the use of the legislative authorization granted by the Law No ___/de ______, pursuant to the

point ( b) of Article 198 (1) of the Constitution, the Government decrees the following:

9

Chapter I

General provisions

Article 1.

Subject

The present decree-law establishes the legal regime of the workshop pharmacies.

Article 2.

Public interest

Pharmacies pursue a health and eye-interest activity and ensure the

continuity of the services they provide to users.

Article 3.

Freedom of installation

The principle of freedom of installation of pharmacies must be respected, provided that

observed the legally anticipated requirements.

Article 4.

Free choice

1-Users have the right to the free choice of pharmacy.

2-The establishments or health services, public or private, as well as the

health professionals prescribers of medications, cannot interfere with the

choice of users, giving them vetted, inter alia, channelling or angling

customers for any pharmacy.

10

Article 5.

Principle of equality

The relationship of pharmacies with the users obeys the principle of equality.

Article 6.

Duty of dispensation of medicinal products

1-The pharmacies have a duty to dispense medications, in the conditions legally

forecasted, save the provisions of the following number.

2-Medical prescription drugs can only be dispensed to users

that they present it, save cases of force majeany, duly justified.

Article 7.

Duty of pharmacovigilance

Pharmacies collaborate with INFARMED on identification, quantification, evaluation and

prevention of the risks of the use of medications, once marketed, allowing the

follow-up of its possible adverse reactions.

Article 8.

Rational use of the medicine

1-The pharmacies promote the rational use of the medicine.

2-The pharmacies make available to users information on the price of

medications essentially similar to the medication requested.

Article 9.

Dispensing sites for medicinal products

The dispensation of medicinal products to the public can only be carried out:

a) By the pharmacies, in their premises, at home or through the Internet ;

b) By the places of sale of medicinal products not subject to medical prescription, in their

facilities, at home or through the Internet .

11

Article 10.

Accessibility to citizens with disabilities

Pharmacies must dispose of conditions allowing access for carriers

of disability to their facilities.

Article 11.

Duty of secrecy

1-People who work in the pharmacies are bound to keep secret from the

facts that have knowledge in the reason of their activity.

2-The duty of secrecy cesses when the revelation becomes necessary to safeguard

interest of sensitive superiority.

Article 12.

Duty of collaboration

1-The pharmacies collaborate with the Public Administration in formulating and implementing

of the policy of the medicine, specifically in the campaigns and programmes of

health promotion and whenever it is cause for the defence of public health.

2-The pharmacies communicate to the INFARMED-National Medication Authority and

Health Products, I. P. (INFARMED), the units of dispensed drugs and

the respective price of sale to the public.

3-The duty of collaboration shall ensure respect for the personal data of users,

specifically those relating to the reservation of the intimacy of private life.

Article 13.

Quality of service

Pharmacies implement and maintain a quality management system aimed at

continuous improvement of the services they provide to users.

12

Chapter II

Regime of title

Article 14.

Property of pharmacies

1-They may be the owner of pharmacies natural persons or commercial companies.

2-In the commercial societies where social capital is represented by shares these

are compulsorily nominative.

3-Social sector entities of the economy may be the owner of pharmacies

provided that they comply with the provisions of this decree-law and too much standards

regulations that bring it to fruition, as well as the tax regime applicable to people

collective referred to in paragraph 1.

Article 15.

Limits

1-No natural person or commercial society may hold or exercise, in

concurrent, directly or indirectly, the property, the holding or the management of

more than four pharmacies.

2-For the fulfillment of the limit referred to in the preceding paragraph are not considered as the

concessions from dispensing dispensing pharmacies to the public in the hospitals of the

National Health Service.

Article 16.

Incompatibilities

They may not detain or exercise, directly or indirectly, the property, exploitation or

the management of pharmacies:

a) Health professionals prescribers of medicinal products;

b) Representative associations of pharmacies, distribution companies

wholesale of medicinal products or companies in the pharmaceutical industry, or of the

respective workers;

c) Wholesale distribution companies of medicines;

13

d) Companies in the pharmaceutical industry;

e) Private companies providers of health care;

f) Subsystems that participate in the price of medications.

Article 17.

Ownership, exploitation or indirect management

It is considered that a person holds the property, exploitation or indirect management

of a pharmacy when the same is detained, exploited or managed:

a) By other persons or entities, in the name of their own or alheio, but on account of

of that, specifically through business management or contract of

mandate;

b) By societies that with it meet in relation to domain or group.

Article 18.

Sale, trespass, leasing and the assignment of exploitation

1-The pharmacies may not be sold, trespassed or leased or the respective

farm to be ceded before after decorating five years, from the day of the respective

opening, in the sequence of public tender.

2-Stay excluded from the provisions of the preceding paragraph the situations properly

justified in the face of INFARMED.

3-Considerate grounds are considered, specifically:

a) The death of the owner;

b) The inability of the owner;

c) The sharing of goods by divorce or judicial separation from the owner;

d) The declaration of insolvency of the owner.

4-A sale, the trespass, the renting and the assignment of the holding shall observe

written form.

5-Legal business provided for in the preceding paragraph shall be communicated to the

INFARMED, by the outwarer referred to in the alvshall or its prosecutor, within 30

days to be counted from the respective celebration, for the effects of averaging on the alvshall.

14

Article 19.

Societies and social participations

The outwarder referred to in the alvshall communicates to the INFARMED, within 30 days, to

averaging effect on the alvshall, the following situations:

a) Dissolution, the merger or the transformation of the proprietary commercial society of

pharmacy;

b) Transmission of social parts, quotas or shares of commercial society

owner of pharmacy, including acts altering the title of the

social participations;

c) Constitution, alteration or extinction of burden that they relapse on the pharmacy.

Chapter III

Technical direction

Article 20.

Technical director

1-A The technical direction of the pharmacy is ensured, in permanence and exclusivity, by

pharmacist technical director, subject to the provisions of paragraph 3 of this Article.

2-The technical director is independent, technically and deontologically, in the exercise of the

respective functions, from the owner of the pharmacy, without prejudice to the situations of

identity between the property and the technical direction of the pharmacy.

3-Must be designated by the owner of the pharmacy, and registered with the INFARMED,

pharmacist, or pharmacists, who replaces the technical director in his absences and

impediments.

4-A The designation referred to in the preceding paragraph shall precede the opening to the public of the

pharmacy.

5-A The owner shall ensure the veracity of the registration referred to in paragraph 3, informing the

INFARMED of the respective changes with a 90-day advance, save

cases of force majeer, duly justified.

15

Article 21.

Duties of the technical director

1-Compete, in particular, to the technical director:

a) Take responsibility for the pharmaceutical acts practiced in the pharmacy;

b) Ensure the provision of clarifications to users on the mode of use

of the medicines;

c) Promoting the rational use of the medicine;

d) Ensuring that prescription drugs are only dispensed with

to users who do not submit it in cases of force majeany, duly

justified;

e) Keep the medications and too much products provided in good condition

conservation;

f) Ensure that the pharmacy is found to be in a condition of proper hygiene and

security;

g) Ensuring that the pharmacy has a sufficient supply of

medications;

h) To ensure that the staff working in the pharmacy keep, on stay,

the asbreast and hygiene;

i) Check the compliance of the deontological rules of pharmaceutical activity;

j) To ensure compliance with the principles and duties provided for in this decree-law and

in the remaining regulatory legislation of pharmaceutical activity.

2-The technical director can be coadjuved by pharmacists and by staff

duly entitled, under your direction and responsibility.

Article 22.

Cessation

1-A cessation of the function of technical director must be communicated, by the owner of the

pharmacy, to INFARMED, in advance of 90 days, save cases of force

greater, duly justified.

2-At the same time with the communication referred to in the preceding paragraph, it shall be indicated

pharmacist who performs the duties of technical director of the pharmacy.

16

Chapter IV

Personnel

Article 23.

Pharmaceutical framework

1-The pharmacies have at least one technical director and another pharmacist.

2-In the situations of processing permanent pharmaceutical posts, pharmacies

may, for two years, have only one technical director.

3-pharmacists should, biased, constitute the majority of workers in the

pharmacy.

Article 24.

Non-pharmaceutical frame

Pharmacists may be coadjured by pharmacy technicians or other staff

legally entitled.

Chapter V

Opening of the pharmacy to the public

Article 25.

Licensing and alvings

1-The licensing of new pharmacies is preceded by public tender.

2-The pharmacies can only open to the public after they are assigned the respective

alvará, issued by INFARMED.

3-A change of the property or the transfer of the location of the pharmacy depend

of averaging in the alvshall.

17

Article 26.

Transfer

The owner may, within the same municipality, transfer the location of the pharmacy,

provided that you observe the conditions of operation.

Chapter VI

Operation of the pharmacy

Article 27.

Designation of the pharmacy

1-The use, in the designation of the pharmacy, of any vocables is prohibited

deceptive or which constitute unfair competition.

2-A The designation of the pharmacy depends on the approval of INFARMED.

3-The vocables "pharmacy", simple or composed, and the symbol "green cross" can only

be used to identify pharmacies, except where the law expressly o

allow.

4-A The configuration of the "green cross" symbol is defined by INFARMED.

Article 28.

Information

1-The pharmacies must disclose, in a visible way, the relevant information in the

relationship with users, specifically:

a) The name of the technical director;

b) The time of operation;

c) The shift pharmacies in the municipality;

d) The discounts they grant in the price of medicines;

e) The way of repayment of the state's comstake in the price of the

medications;

f) The existence of a book of complaints.

2-Outside of the pharmacies is inscribed the vocables "pharmacy" or the symbol " cross

green ".

18

3-When the pharmacy is on shift, the vocacula "pharmacy" or the symbol " cross

green ", should, where possible, be illuminated during the night.

Article 29.

Facilities

1-The pharmacies must have adequate facilities to ensure:

a) The safety, conservation and preparation of medicinal products;

b) The accessibility, convenience and privacy of users.

2-For the purposes of the provisions of the preceding paragraph, pharmacies must dispose of,

specifically, of the following divisions:

a) Room for service to the public;

b) Warehouse;

c) Laboratory;

d) Sanitary facilities.

3-The minimum areas of pharmacies and of each of the divisions referred to in the number

previous are defined by INFARMED.

Article 30.

Time of operation

The time of operation of pharmacies covers the operating periods,

daily and weekly, and the permanent service shifts, of reinforcement and regime arrangements

of availability, regulated in a diploma of their own.

Article 31.

Mandatory eviction

The staff who perform duties at the pharmacy, including the technical director, others

pharmacists and pharmacy technicians, are estranged from their place of work when

hit by mandatory eviction disorders, on the same terms in which it allows the

temporary removal of school attendance and too much activities developed in the

education and educational facilities for discents, teaching staff and not

lecturer.

19

Article 32.

Identification

Staff who perform public service roles in pharmacies should be

duly identified, upon the use of a card, containing the name and the title

professional.

Article 33.

Authorized products

Pharmacies can provide the public with:

a) Medications;

b) Medicated substances;

c) Medicinal products and veterinary products;

d) Medicines and homeopathic products;

e) Natural products;

f) Medical devices;

g) Food supplements and special food products;

h) Plant protection products;

i) Cosmetic and body hygiene products;

j) Articles of puericulture;

l) Products of comfort.

Article 34.

Conservation and shelf life

1-In pharmacies there can be no products in a bad state of conservation.

2-The pharmacies cannot provide products that exceed the shelf life.

Article 35.

Medications sold out

1-The pharmacies must provide, with the brevity possible, by obtaining the

20

requested medications that are found to be depleted.

2-A dispensation of medications obtained in the terms of the preceding paragraph is untenable

to originate any payment addition.

Article 36.

Pharmaceutical services

Pharmacies can provide pharmaceutical services for promotion of health and good-

be of the users.

Article 37.

Documents

The pharmacies dispose of them at their premises:

a) Of The Portuguese Pharmacopoeia, in paper edition, in electronic form or

online , from the site of the Internet recognized by INFARMED;

b) From other documents indicated by INFARMED.

Article 38.

Complaints

1-The pharmacies have a book of complaints.

2-The pharmacies send monthly to INFARMED copy of the complaints

performed by users.

3-INFARMED makes available, on its website Internet , an area intended for the

complaints from users.

Chapter VII

Closure of the pharmacy

Article 39.

Communication

Save cases of force majeany, duly justified, pharmacies can only shut down

21

after communication to INFARMED, in advance of 90 days.

Article 40.

Maintenance in operation

1-If the closure is critically injured for the public interest, the INFARMED

provision for the maintenance of a functioning pharmacy that guarantees the

accessibility of users to the dispensation of medicines.

2-For the purposes of the provisions of the preceding paragraph, the INFARMED may, in particular:

a) Notify the owner to keep the pharmacy in operation, with the

cessation comination of the alvshall;

b) Assign the provisional exploitation of a pharmacy to a pharmacist, if the

owner does not ensure the maintenance of the pharmacy in operation.

3-A assignment of the provisional exploitation of a pharmacy determines the immediate

open competition for the licensing of new pharmacy and cessa with the

allotment of the new alvshall.

Article 41.

Reopening

1-Without prejudice to the provisions of the previous article, the pharmacy which, after operating

for the minimum period of one year, be voluntarily closed may reopen, without

further formalities, within one year, from the date of the closure, since

that such a fact is communicated to INFARMED, in advance of 30 days.

2-Cessa the right to reopen the pharmacy 60 days after the notification of the owner for the

make, with the comination of this right lapse by the opening of new contest

public and of the consequent cessation of their alvshall.

Article 42.

Shutdown

1-The pharmacies, mobile pharmaceutical posts and permanent pharmaceutical posts

may be terminated by INFARMED when they do not meet the requirements of

opening and operating.

22

2-If the default referred to in the preceding paragraph does not affect the public health and the

trust of users, the closure may be temporary and limited to the period

necessary to the correction of the disconformities detected.

3-If the owner does not shut down the pharmacy after the obligation to practise such an act

be notified to you, INFARMED executes it coercively, staying the expenses by

account of the thank you.

Chapter VIII

Pharmaceutical posts

Article 43.

Permanent pharmaceutical posts

1-Can be turned into pharmacies the permanent pharmaceutical posts that

meet the respective conditions of operation.

2-A opening of pharmacies pursuant to the preceding paragraph depends on prior assignment

of alvará.

Article 44.

Mobile pharmaceutical posts

1-Each pharmacy can hold two mobile pharmaceutical posts.

2-Mobile pharmaceutical posts are the subject of averaging in the alvshall of the pharmacy a

who respect.

3-A The opening of mobile pharmaceutical posts depends on the authorisation of INFARMED.

4-The INFARMED defines, in relation to each mobile pharmaceutical post, the respective

geographical area of acting.

5-The operating requirements of mobile pharmaceutical posts are defined by the

INFARMED.

Chapter IX

Supplementary provisions

23

Article 45.

Surveillance

1-Unless otherwise determined, the monitoring of compliance with the provisions of the

present decree-law is up to INFARMED.

2-INFARMED may request the aid of other entities, namely

police authorities, in the performance of the supervisory functions.

3-INFARMED should collaborate with the Order of Pharmacists and communicate it to

offences whose sanctionatory procedure is in their jurisdiction.

Article 46.

Agents

The owners of the pharmacies are held to account counterordinationally by the

practice of the counter-ordinations provided for in this chapter.

Article 47.

Serious counterorders

1-Constituent counterordinance punishable, in the case of natural persons, with fine of €

500 a to € 5000 and, in the case of legal persons, with fine of € 5000 a € 20000:

a) The violation of the duty of pharmacovigilance, provided for in Article 7;

b) The violation of the duty of information on the price, provided for in Article 2 (2)

8.

c) The violation of the duty of collaboration, provided for in Article 12;

d) Failure to comply with written form in the legal business provided for in paragraph 4

of Article 18;

e) Non-communication, in accordance with Article 18 (5);

f) The failure to comply with the obligation laid down in Article 19;

g) The violation of the provisions of Article 22 (1) and (2);

h) The use of an unapproved designation, in violation of Article 27;

i) The violation of the information obligations provided for in Article 28;

j) The non-existence of the facilities, divisions or conditions of access provided for in the

n. paragraphs 1, 2 and 3 of Article 29;

24

l) Failure to comply with the duty of identification provided for in Article 32;

m) Violation of the provisions of Article 37;

n) The infringement of the provisions of Article 39.

2-Constituent counterordinance punishable with fine of € 5000 a € 20000, the fact that:

a) The property of pharmacy belongs to the legal person who does not assume the

form of commercial society;

b) The shares of the proprietary commercial companies of pharmacies are not

nominations.

Article 48.

Counter-very serious counterorders

Constitutes counterordinance punishable, in the case of natural persons, with a fine of €

5000 a to € 20000, and in the case of legal persons, with a fine of € 20000 a € 50000:

a) The violation of the duty of dispensation of medicinal products, provided for in Article 6;

b) The violation of the duty of secrecy, provided for in Article 11;

c) The arrest or the exercise, simultaneously, directly or indirectly, of the

property, exploitation or management of more than four pharmacies, in

violation of the provisions of Article 15;

d) The arrest or the exercise, directly or indirectly, of the property, of the

operating or the management of pharmacies by the persons or entities referred to in the

article 16;

e) The sale, the trespass, the leasing or the assignment of the farm's farm

before decorating five years, from the day of the opening to the public, in

violation of the provisions of Article 18;

f) The violation of the provisions of Article 20 (1) of the Article;

g) Failure to comply with the duties of the technical director provided for in paragraph 1 of the article

21.

h) The existence of a pharmaceutical framework that does not comply with the provisions of the article

23.

i) The opening of the pharmacy to the public without the allocation of the respective alvshall or the

lack of averaging in cases of alteration of the property or transfer

of the location, provided for in Article 25;

j) The supply to the public of unauthorized products, in violation of the article

25

33.

l) The existence, in pharmacies, of products in a bad state of conservation or the

supply of medicines that exceed the shelf life, in violation

of the provisions of Article 34;

m) The collection of extra payment for the dispensation of medicines

depleted, in violation of the provision of Article 35 (2);

n) The non-existence of a book of claims, in violation of the provisions of Article 38;

o) The transformation of permanent pharmaceutical posts into pharmacies in

violation of the provisions of Article 43 (2), or which do not assemble the respective

conditions of operation;

p) The opening of mobile pharmaceutical posts in violation of the provisions of the article

44.

Article 49.

Ancillary sanctions

They may be applied, at the same time as the fines provided for in Articles 47 and 48, the

following ancillary sanctions:

a) Loss of objects belonging to the agent;

b) Closure of the establishment;

c) Suspension of the alvshall;

d) Deprivation of the right to participate in public tenders that have by

object to the granting of public services or the allocation of licences or

alvarás.

Article 50.

Specific counterordinance

1-Health care professionals prescribers of medications that interfere with the choice

of the users, in violation of the provisions of Article 4 (2), are punished with fine

from 5000 a to € 20000.

2-The private health establishments or services, which interfere with the choice of the

users, in violation of the provisions of Article 4 (2), are punishable by fine

20000 a to € 50000.

26

Article 51.

Processing

The processing of the counter-ordinations and the application of the fines is to the

INFARMED.

Article 52.

Nullity

1-Are void the legal business concluded against the provisions of this decree-law or

that they produce, or can produce, a practical effect identical to what the law wanted

ban.

2-It Is Incumbent on the Ministry of Health, officiously or in the wake of the initiative of the

INFARMED, propose the actions of nullity and apply for the arrangements that the case

couberin to prevent the legal business from being concluded in an infringement or

fraud to the law produce effects.

Article 53.

Notaries

Notaries must communicate to INFARMED all legal business that, direct

or indirectly involve, in whole or in part, the alteration of the property, of the

operation or management of a pharmacy.

Chapter X

Transitional provisions

Article 54.

Formal transitional standard

1-A The transformation of permanent pharmaceutical posts into pharmacies may occur

within one year.

2-Permanent pharmaceutical posts that do not turn into pharmacies in the

27

term referred to in the preceding paragraph are closed.

Article 55.

Material transient standard

To public tenders for the licensing of pharmacies applies to legislation in

vigour in the time of the respective opening.

Chapter XI

Final provisions

Article 56.

Regulation

The member of the Government responsible for the area of Health regulates, by portaria, in the

deadline of 120 days after the entry into force of this decree-law:

a) The form of the communication to INFARMED of the obligations provided for in the present

decree-lei;

b) The conditions and requirements of the dispensation of medicines at home and

through the Internet ;

c) The procedure for the licensing of pharmacies and alvaceous allocation;

d) The definition of the pharmaceutical services that can be provided by the

pharmacies;

e) The procedure and requirements for allocation of alvings to pharmacies that

result from the transformation of permanent pharmaceutical posts.

Article 57.

Private institutions social solidarity

The pharmacies which, at the date of entry into force of this decree-law, are the property of

private institutions solidarity social solidarity, and while they are, they do not have to obey

to the requirements set out in Article 14 of this Decree-Law

28

Article 58.

Site in the Internet

The INFARMED ensures, at its site in the Internet , an area intended for communications

of the pharmacies, specifically those provided for in Articles 8, 12, 18 to 20, 31, 31,

38., 39 and 41.

Article 59.

Abrogation standard

1-The following diplomas are revoked:

a) Law No. 2125 of March 20, 1965;

b) Decree-Law No. 48547 of August 27, 1968.

2-References made in legal or regulatory diplomas to the repealed standards in the

previous number consider themselves to be made for the corresponding standards in force.

Article 60.

Entry into force

This decree-law shall come into force 60 days after its publication.

Seen and approved in Council of Ministers of

The Prime Minister

The Minister of Justice

The Minister of Labour and Social Solidarity

The Minister of Health