FAQ
Frequently Asked Questions |
|||
• |
General |
||
• |
|||
• |
|||
• |
|||
• |
Veterinary medicinal products |
||
• |
Vigilance |
||
|
- |
||
|
- |
Health Products |
|
|
- |
Medical devices |
|
• |
|||
• |
Health products |
||
|
• |
Medical devices |
|
|
- |
||
|
- |
In vitro Diagnostic Medical Devices (IVDDs) and applicable Legislation |
|
|
- |
||
|
- |
Homeopathic pharmaceutical products |
|
|
- |
Plant-based natural products |
|
• |
|||
|
- |
Manufacturers |
|
|
- |
||
|
- |
Wholesalers |
|
|
|
|
|
• |
|||
What is INFARMED – National Institute of Pharmacy and Medicines? |
||
|
INFARMED is the national regulatory authority of the Health Ministry, that evaluates, authorises, regulates, inspects and controls the manufacturing, distribution, sale and use of medicinal products for human and veterinary use, including plant-based and homeopathic products as well as health products (which include cosmetics and personal hygiene products, non-active medical devices, in vitro diagnostic medical devices and homeopathic pharmaceutical products). |
|
Does INFARMED manufacture or sell medicinal products? |
||
|
No. It simply regulates their evaluation, authorisation, supervision, manufacturing, control and inspection, distribution, sale and use. |
|
|
|
|
How does INFARMED ensure that the medicinal products on the market are safe, effective and of good quality? |
||
|
By means of: |
|
|
- |
Scientific assessment of all medicinal products before they are placed onto the market. |
|
- |
Licensing and periodic inspections of establishments manufacturing, distributing and marketing medicinal products. |
|
- |
Monitoring quality control of the medicinal products on the market, by means of periodic analysis. |
|
- |
Vigilance in regard to adverse medicine reactions. |
|
- |
Provision of up-to-date and reliable information for consumers and health professionals. |
|
Veterinary Medicinal Products |
||
Veterinary Medicinal Product Regulatory Body. |
||
|
|
INFARMED is responsible for issuing Marketing Authorisations for Veterinary Medicinal Products. (See Chap. II -Section I - Article 4 - Decree-Law no. 184/97 ). |
|
|
|
The nature of a Veterinary Medicinal Product. |
||
|
|
"Any substances or combination of substances which may be administered to animals with a view to preventing, diagnosing or treating diseases or correcting/modifying physiological function processes". (See article1 - Title 1 of Directive 2001/82/EC of 6 th November ). |
The difference between a Medicinal Product for Veterinary and for Human Use. |
||
|
|
Veterinary Medicinal Products / Human Medicinal Products |
The nature of the SPC (Summary of Product Characteristics). |
||
|
|
|
Access to SPCs for Veterinary Medicinal Products. |
||
|
|
SPCs for Veterinary Medicinal Products may be consulted on the INFARMED " homepage ". |
The meaning of off-label use of Veterinary Medicinal products. |
||
|
|
When the medicine is used/administered under conditions not laid down in the authorised SPC in line with article 62 of Decree-Law no. 184/97 of 26th July. |
Obtaining a Veterinary Medicinal Product with no Marketing Authorisation in Portugal . |
||
|
|
This may be done in accordance with Article 20 of Decree-Law no. 184/97 of 26th July, and Joint Ministerial Order 317/99 of 15 th April 1999. |
Importing Medicinal Products for Human Use with no MA in Portugal to administer to animals. |
||
|
|
|
Can a Veterinary Doctor acquire Medicinal Products for Human Use? |
||
|
|
Yes, if there are no alternative veterinary treatments. |
Obtaining a Medicinal Product for Human Use – exclusive to Hospitals (e.g. Vincristin, Vitamin K1, etc). |
||
|
|
This may be done in accordance with Article 87 of Decree-Law no. 184/97 of 26th July, and Joint Ministerial Order 730/98 of 17 th October. |
Documentation required to make an application for essentially similar Veterinary Medicinal Products. |
||
|
|
Please see: |
|
As a rule the applicant shall provide: |
|
|
|
1) Parts I and II of the Medicinal Product dossier; |
Types of variations to Marketing Authorisation. |
||
|
|
|
Fees for Mutual Recognition and National Marketing Authorisations, Variations and Renewals for Veterinary Medicinal Products. |
||
|
|
|
Bank Account for paying fees relating to Veterinary Medicinal Products. |
||
|
|
Fees must be deposited in the name of Medicinal Products for Veterinary Use Technical Commission: |
Length of time required to approve a Veterinary Medicinal product. |
||
|
|
National - 210 days - consult article 11 of Decree-Law no.184/97 |
Definition of Maximum Residue Limit (MRL). |
||
|
|
The Maximum Residue Limit is the maximum concentration of residues, expressed in mg/Kg or µ/Kg on a fresh weight basis, which is a legal and acceptable value in products of animal origin. |
|
|
Since 1 st January 1992, no Member-State has been able to authorise Medicinal Products for Veterinary Use to be used in animals intended for human consumption without the MRL of the active substances being clearly defined. Between 1992 and 1999 the EMEA (European Agency for the Evaluation of Medicinal Products) evaluated the safety of some active substances for animals intended for human consumption, including those in annexes I, II, III and IV of Regulation 2377/90. Since 1 st January 2000, it has not been possible to use any active substance in a Veterinary Medicinal Product intended for food-producing animals unless it is included in annexes I, II and III of the above Regulation. |
|
|
|
Publication of amendments to Regulation 2377/90 (MRL) Annexes. |
||
|
|
|
Definition of Safety Interval (SI). |
||
|
|
Under Article 2 (q), Definitions, of Decree-Law no. 184/97 of 26th July, the Safety Interval corresponds to that “period of time between the final administration of a veterinary medicinal product, under normal conditions of use, and the obtaining of foodstuffs from that animal, in order to ensure that they do not contain quantities of residues greater than the MRL (maximum residue limits) laid down in Council Regulation (EEC) no. 2377/90 , of 26th July, and later amendments.” – Link to Risk analysis/ Antimicrobial resistance / Safety interval. |
Veterinary Medicinal Product Circuit. |
||
|
|
Distribution of Veterinary Medicinal Product s. See Chapter V of Decree-Law no. 184/97 of 26th July. |
Does INFARMED sell Veterinary Medicinal Products? |
||
|
|
INFARMED, as the entity responsible for issuing Marketing Authorisations for Medicinal Products, is not entitled to sell such products. |
Can a Veterinary Doctor sell Veterinary Medicinal Products? |
||
|
|
A Veterinary Doctor may not sell Veterinary Medicinal Products. He/she may in the course of a consultation use them or prescribe them to be dispensed at a Pharmacy. |
Can Veterinary Medicinal Products be sold separately in pet shops? |
||
|
|
Veterinary Medicinal Products may not be sold in pet shops. Only pharmacies may dispense Veterinary Medicinal Products and the packaging may not be broken to dispense part of the contents. |
Places where Veterinary Medicinal Products may be advertised. |
||
|
|
Only Medicinal Products not requiring a medical prescription may be advertised. Health professionals may receive information in the form of specialist journals or copies of the SPCs. (See article 71 of Decree-Law no. 184/97 of 26th July). |
Centralised Procedure – obtaining a centrally-approved MA Marketing Authorisation (MA) for Veterinary Medicinal Products |
||
|
|
In order to obtain a centrally-approved MA for Veterinary Medicinal Products that meet the requirements of the Annex to Council Regulation (EEC) no. 2309/93, of 22 nd July, the application must be submitted to the European Agency for the Evaluation of Medical Products (EMEA). When a Veterinary Medicinal Product receives Marketing Authorisation it is given a Community Registration no.(s) (EU/ 2/ ../ .../ ... ). The MA is then valid in all European Community Member-States. |
Centralised Procedure - Community Registration no. and National Code no.. |
||
|
|
When a Veterinary Medicinal Product is granted a Marketing Authorisation under the centralised procedure it is given a Community Registration no.(s) ( EU/ 2/ ../ .../ ... ). |
How can I access information about the data on the international network of national antimicrobial resistance surveillance systems, relating to strains of relevance to Public Health - S. pneumoniae, S. aureus, E. coli, e E. faecium/faecalis ? |
||
|
|
|
The ATCvet classification system. |
||
|
|
The ATCvet classification system covers substances for therapeutic use and may be used to classify Veterinary Medicinal Products. |
What is a medicinal pre-mix? |
||
|
|
"Any veterinary medicinal product, in an appropriate medium, prepared in advance with a view to later manufacture of medicated foodstuffs." (See article 2 Chapter I of Decree-Law no.184/97 ). |
-VIGILANCE – MEDICINAL PRODUCTS
Vigilance - Medicinal Products |
|
When was the National Pharmacovigilance System introduced? |
|
|
In 1992 |
|
|
How is the National Pharmacovigilance System regulated? |
|
|
In accordance with Decree-Law no. 242/2002 of 5 th November |
What is an adverse reaction? |
|
|
There are many possible definitions. WHO defines an adverse reaction as "Any untoward and unintended reaction to a medical product which occurs at doses normally used to prevent, diagnose or treat a disease or to modify physiological functions". |
What should be reported? |
|
|
Serious or unexpected adverse reactions. If you are in any doubt as to a possible adverse reaction, you should inform your health professional. |
What is a serious adverse reaction? |
|
|
Any reaction that results in death, is life-threatening, requires or prolongs hospitalisation, results in a significant or persistent disability or is a congenital anomaly or birth defect, or is deemed by the health professional to be “medically important". |
What is an unexpected adverse reaction? |
|
|
Any reaction not described in the Summary of Product Characteristics (SPC). This definition includes reactions the nature, severity or development of which are not consistent with the SPC. |
How should I report an adverse reaction? |
|
|
Use the special forms (yellow for doctors, purple for pharmacists and white for nurses). If these forms are not available, any other reporting form is acceptable, including a telephone call (21-7987141), a fax (21-7987155) or e-mail (uram@infarmed.pt ). |
Who should be notified of possible adverse reactions? |
|
|
Any entity belonging to the National Pharmacovigilance System, be it INFARMED's Pharmacovigilance Operational Division or the Pharmacovigilance Units ( Azores , North, Centre and South) depending on the geographical location of the person reporting the adverse reaction. In case of doubt, any of the above bodies may be notified. |
Who should report adverse reactions? |
|
|
Doctors, Pharmacists, Nurses and other health professionals, in addition to the cases reported to INFARMED by the Pharmaceutical Industry. |
How many reports are made each year? |
|
|
In 2000, 2001 and 2002 the number of reports was 642, 1342 and 1263 respectively. These figures are still well below the levels expected for a population our size, which should be around 2500 per year. |
Who is the Portuguese competent authority for medical devices vigilance? |
|
|
INFARMED is the Portuguese competent authority for the vigilance of active non implantable and non active medical devices. The recent publication of Decree-Law n.er 76/2006 will soon create a single national competent authority with the transfer of active implantable medical devices from INSA Dr. Ricardo Jorge to INFARMED. |
|
|
How is the national medical devices vigilance system regulated? |
|
|
This is regulated in accordance with Portaria n.er 196/2004 of March 1 . This law is based on European guideline MEDDEV 2.12/1 (rev. 4) and GHTF agreements. |
Who should report incidents involving medical devices? |
|
|
The manufacturer or authorised representative shall report to INFARMED all incidents and field safety corrective actions (FSCA) involving medical devices. Additionally, INFARMED encourages users (especially healthcare workers) and other professionals involved in distribution, delivery or putting into service of medical devices to report incidents. |
How should an adverse event be reported? |
|
|
All the necessary information could be gathered, for your convenience, in the form of a report. We have, available on this website ( MD and IVDMD ), several forms adapted to the different needed procedures. However, the use of these forms in not mandatory, as long as the contents are respected. |
- MEDICAL DEVICES AND APPLICABLE LEGISLATION
Medical devices |
Medical devices (MD) CONTENTS
- What are active medical devices?
- What are clinical research medical devices?
- What are custom-made medical devices?
- What are medical device systems and sets for medical procedures?
- Where is the boundary between medical devices and other products?
- Is the distributor responsible for placing medical devices on the market?
- What is the legal definition of a manufacturer?
- Who is an authorised representative?
- How are medical devices classified?
- How are the classification criteria defined?
- What does the CE marking on medical devices mean?
- What are the characteristics of a medical device bearing the CE marking?
- What does the code number following the CE marking stand for?
- Who controls the medical devices placed on the market?
- What are the Competent Authority's functions?
- Who checks whether a medical device meets the essential requirements laid down by law?
- Which documents can prove the authenticity of the CE marking?
- How can I recognize a EC Certificate of Conformity?
- How can I obtain a CE marking for medical devices? What is a medical device? Any instrument, apparatus, appliance, material or other article whether used alone or in combination, including the software for its proper application, intended by the manufacturer to be used for human beings for the purpose of: • diagnosis, prevention, monitoring, treatment or alleviation of disease , • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap , • investigation, replacement or modification of the anatomy or of a physiological process, • control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
What are active medical devices? Any medical device operation of which depends on a source of electrical or other energy source of power other than that directly generated by the human body or by gravity and which acts by converting this energy is called an active medical device.
The term does not apply to devices intended to transmit energy, substances or other elements between an active medical device and the patient, without any significant change. What are devices intended for clinical investigation ? What are custom-made medical devices? Custom-made medical devices are specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient.
What are medical device systems and sets for medical procedures?
Where is the boundary between medical devices and other products? Is the distributor responsible for placing the medical devices on the market? No, the distributor, as the name implies, is the entity responsible for distributing the medical devices. Under the law the only entity responsible for placing them on the market is the manufacturer. Only the manufacturer may request an evaluation of the devices conformity and place them on the market under his own name.
What is the legal definition of a manufacturer? Who is an authorised representative? When a medical device manufacturer has his head office outside the European Economic Area (EEA), he must be represented by an authorised representative established in the Community. The representative assumes the manufacturer's liability before the authorities and other official bodies in the Community. How are medical devices classified? Medical devices are divided into four risk classes: • Class I medical devices - low risk • Class IIa medical devices – medium risk • Class IIb medical devices - medium risk • Class III medical devices – high risk
The risk class is calculated taking into account the following factors: 1- Length of time in contact with the human body (Transient, short-term and long-term) 2- Degree of invasion of human body (Invasive, non-invasive) 3- Part of anatomy affected by its use (Brain, heart, lower limbs, etc. ) 4- Potential risks stemming from technical design or manufacture How are the classification criteria defined? What are the characteristics of a medical device bearing the CE marking?
What does the code number following the CE marking stand for? What is the Notified Body? • conduct the conformity evaluation procedures; • authorise the affixing of the CE marking; • issue conformity certificates: • renew, or not, certificates of conformity; • ensure that the manufacturer complies fully with his duties under the approved quality system; • cooperate with the National Authorities; • cooperate with other Notified Bodies in EU Member-States. Who controls the medical devices placed on the market? The Portuguese Competent Authority acts on behalf of the government to ensure that Community Directives are implemented in the country. Portuguese Authorities: Dr. Ricardo Jorge National Health Institute (INSA) for: • Implantable active medical devices • Active medical devices National Institute of Pharmacy and Medicines (INFARMED) for: • Non-active medical devices • In vitro diagnostic medical devices • Surveillance of non-active and active medical devices What are the Authority's functions? The Authority's functions in the field of medical devices are as follows: • Adopt and publish the rules and regulations required to implement Directives; • Appoint the Notified Bodies; • Take part in European Union working parties and standing committees; • Settle disputes between Manufacturers and Notified Bodies; • Assess applications for clinical research medical devices; • Evaluate notices relating to and keep records of class I medical devices and custom-made devices manufactured in Portugal or other countries; • Monitor the after-sales stage of the medical devices market; • Take part in the setting up of a European medical devices database; • Check all information received in regard to medical devices sold in Portugal , from both manufacturers and distributors; • Surveillance of medical devices. Who checks whether the medical devices meet the essential requirements laid down by law? • Draw up a Declaration of Conformity • Notify the Competent Authority of his address and describe the products he manufactures; • Receive the Authority's inspectors for health protection purposes • In the case of class IIa, IIb and III devices and all sterile or measuring devices placed on the market, the notified body chosen by the manufacturer must play a part and may issue a Certificate of Conformity. Which documents can prove the authenticity of the CE marking? • A EC Declaration of Conformity drawn up by the manufacturer and the notice of sale of class I devices provided to the Competent Authority, • Notice of sale of custom-made or clinical research devices the manufacturer provided to the Competent Authority, • A EC Certificate of Conformity issued by the notified body responsible for evaluating the conformity of class IIa, IIb and III devices and of sterile or measuring class I devices. How can I recognize a EC Certificate of Conformity? A certificate must include: • A reference to the applicable Directive • The procedure followed and a reference to the respective annex(es) • A description of the devices concerned • Name and address of the manufacturer or authorised representative established in the European Union • Issue date of Certificate • Validity period • Name and identity number of the Notified Body responsible for issuing the certificate How can I obtain a CE marking for medical devices? - Custom-made devices The Manufacturer shall draw up the Declaration of Conformity referred to in annex VIII of Decree-Law no. 30/2003 of 14 th February and comply with the provisions thereof. - Clinical research devices The Manufacturer shall draw up the Declaration of Conformity referred to in annex VIII of Decree-Law no. 30/2003 of 14 th February and comply with the provisions of annexes VIII and X.
-Class I devices The Manufacturer shall follow the procedures set out in annex VII of Decree-Law no. 30/2003 of 14 th February and draw up the EC Declaration of Conformity.
- Class I sterile and measuring devices The Manufacturer shall draw up a EC Declaration of Conformity in accordance with annex VII of Decree-Law no. 30/2003 14 th February and choose one of the following evaluation procedures: - annex IV, - annex V, or - annex VI. -Class IIa devices The Manufacturer shall choose one of the following evaluation procedures referred to in Decree-Law no. 30/2003 of 14 th February: - annex II, or - annex VII together with one of annexes IV, V or VI. - Class IIb devices The Manufacturer shall choose one of the following evaluation procedures referred to in Decree-Law no. 30/2003 of 14 th February: - annex II, or - annex III together with one of annexes IV, V or VI. - Class III devices The Manufacturer shall choose one of the following evaluation procedures referred to in Decree-Law no. 30/2003 of 14 th February: - annex II, or - annex III together with one of annexes IV or V. |
In vitro diagnostic medical devices(IVDDs) and applicable legislation
Medical devices |
|
In vitro diagnostic medical devices (IVDDs) CONTENTS
- What is the definition of a in vitro diagnostic medical device (IVDD)? - Under Decree-Law no. 189/2000 of 12 th August, an IVDD is: - Who controls the medical devices placed on the market? - What are the Competent Authority's functions? - What does the CE marking on medical devices mean? - When does it become compulsory to affix the CE marking on IVDDs available on the Portuguese market? - What are the duties of the Portuguese distributor of IVDDs bearing the CE marking? - Can the distributor affix the CE marking? - What is the definition of a “manufacturer”? - What must an IVDD manufacturer established in Portugal do to obtain the CE marking for his products? - Which entities are involved in the evaluation of IVDD conformity?
What is the definition of a In vitro diagnostic medical device (IVDD)?
• any In vitro diagnostic medical device which is a reagent, reagent product, kit, calibrator and control material , intended to be used, in vitro , to diagnose or monitor states of health, disease or congenital anomaly by testing human body samples, including self-test devices to be used by non-professionals.
Under Decree-Law no. 189/2000 of 12 th August, an IVDD is: • container(s) specifically designed by the manufacturer to contain or preserve samples derived from the human body intended for in vitro diagnosis; • accessories which are specifically designed by the manufacturer to be used together with In vitro diagnostic medical device .
Who controls the medical devices placed on the market? Portuguese Authorities: Dr. Ricardo Jorge National health Institute (INSA) for: • Implantable active medical devices • Active medical devices National Pharmacy and Medicines Institute (INFARMED) for: • Non-active medical devices • In vitro diagnostic medical devices • Surveillance of non-active and active medical devices
What are the Authority's functions? • Adopt and publish the rule and regulations required to implement Directives; • Appoint Notified Bodies; • Take part in European Union working parties and standing committees; • Settle disputes between Manufacturers and Notified Bodies; • Assess applications for clinical research medical devices; • Evaluate notices relating to and keep records of class I medical devices and custom-made devices produced in Portugal or other countries; • Monitor the after-sales stage of the medical devices market; • Take part in the setting up of a European medical devices database; • Check all information received in regard to medical devices sold in Portugal from both manufacturers and distributors; • Surveillance of medical devices.
What does the CE marking on medical devices mean? The presence of the CE marking in is a prerequisite for medical devices to be placed on the market and be allowed to circulate freely. It is a guarantee that the products conform to the essential requirements to which they are subject.
When does it become compulsory to affix the CE marking on IVDDs available on the Portuguese market?
What are the duties of the Portuguese distributor of IVDDs bearing the CE marking? • The distributor must guarantee that the device's labelling and instructions are written in Portuguese . • The distributor must i nform INFARMED of the name and address of his head office and provide a list of the products to be sold, together with the technical documents needed to calibrate them periodically (in accordance with Article 12 of Decree-Law no. 189/2000).
Can the distributor affix the CE marking?
What is the definition of a “manufacturer”? A “Manufacturer” is the natural or legal person responsible for the design, manufacture, packaging and labelling of a device, before it is placed on the market under his own name, regardless of whether these operations are carried out by that person or by a third party on his behalf.
How should a manufacturer whose head office is not in Portugal notify INFARMED that it has placed IVDDs bearing the CE marking on the market? • indicating which devices he intends to place on the Portuguese market; • supplying the information laid down in article 10 of Decree-Law no. 189/2000, which should be submitted using the appropriate form " Form for the registration of manufacturers and devices In Vitro Diagnostic Medical Device Directive: article 10 ”, and completing all items applying to the device. The manufacturer should preferably send a copy of the form submitted to the Competent Authority in the country where he is established; • supplying the certificates issued, modified, completed, suspended, withdrawn or refused by the Notified Body – for the devices listed in Annex II or which are intended for self-diagnostic use; • supplying the instructions leaflet (IL) and the planned labels, necessarily written in Portuguese pursuant to Article 5 of Decree-Law no. 189/2000, for the devices listed in Annex II or which are intended for self-diagnostic use.
What are the requirements for labelling and other information to be provided by the manufacturer of IVDDs intended for the Portuguese market? The labelling and IL shall also comply with the provisions of point 8, Annex I of the same Decree-Law.
What must an IVDD manufacturer established in Portugal do to obtain the CE marking for its products? Which entities are involved in the evaluation of IVDD conformity? The conformity of IVDDs that do not constitute a risk when used by duly qualified professionals may, generally speaking, be evaluated on the basis of internal quality control procedures carried out under the sole responsibility of the manufacturer (Annex III of Decree-Law no. 189/2000). IVDDs listed in Annex II and IVDDs for self-diagnosis, since they belong to a group of devices whose proper operation is essential to clinical practice and to Public Health safety, require the participation of a Notified Body and the application of stricter evaluation procedures that guarantee the highest degree of safety and reliability.
What is the Notified Body? • conduct the conformity evaluation procedures; • authorise the affixing of the CE marking; • issue certificates of conformity; • renew, or not, certificates of conformity; • ensure that the manufacturer complies fully with his duties under the approved quality system; • cooperate with National Authorities; • cooperate with other Notified Bodies in EU Member-States.
Which procedures should “reagent or product” importers follow to clear their products through customs? 1. Any products that may be deemed an IVDD (under the legal definition) may require an Infarmed declaration to clear customs. In such circumstances the importer should ask for a declaration from Infarmed's President by applying to INFARMED's Medical Devices Department (DIM/DMPS). 2. Along with the above declaration, all the documentation requested of the manufacturer should be provided to show that:
- the product is an IVDD and complies with the legislation in force; or
- the product is intended solely for research. In such cases, when the devices are covered by article 2 (2) (c) of Decree-Law no. 306/97, all documentation relating to the research in which the IVDD is to be used should be provided, in particular the summary protocol, the person in charge, the place and duration of the research.
|
|
Homeopathic pharmaceutical products
Plant-based natural products
Manufacturers, Distributors e Wholesalers |
||
Direct purchase |
||
|
What is direct purchase? |
|
|
Under article 62 (1) of Decree-Law no. 72/91 of 8 th February (Medicine Statute) , as amended by Decree-Law no. 272/95 of 23 rd October: |
|
|
Manufacturers, importers and wholesalers may only sell Medicinal Products directly to pharmacies and, if so authorised by INFARMED, following an opinion from the Enterprise Directorate-General, they may also: |
|
|
a) |
Trade Medicinal Products freely between themselves; |
|
b) |
Sell Medicinal Products to public and private health establishments and services, and to not-for-profit social welfare institutions that offer a medical or pharmacy service and/or hospitalisation, provided the Medicinal Products purchased are for own consumption. |
|
Thus the applicant shall lodge a duly drawn up request for permission to acquire medicinal products directly with INFARMED, together with the legally required documents, including the pharmacist's Acceptance of Liability and the list of Medicinal Products to be purchased. |
|
Manufacturers
Distributors |
||
What requirements must be met to distribute Medicinal Products? |
||
|
Wholesale distribution of Medicinal Products is governed by Decree-Law no. 135/95 of 9 th June, published in DR I, no. 134 of 09/06/95 . Under the terms of article 3 (1) of that Instrument, wholesale distribution requires authorisation from INFARMED's Executive Board. |
|
|
Nonetheless, article 3 (2) of the same Instrument foregoes the need for authorisation in the circumstances set out in subparagraphs a) and b): |
|
|
a) |
Distribution by the legitimate holder of the manufacturing authorisation, provided that he only distributes the Medicinal Products he manufactures and does not possess premises dedicated to wholesale distribution of Medicinal Products; |
|
b) |
Distribution of Medicinal Products by holders of a Medicinal Products wholesale distribution licence granted by a European Union Member-State who do not possess premises dedicated to such activity. |
|
Even so, article 3 (3) explains that the authorisation exemption referred to in no.1 does not excuse the interested parties from complying with all the other duties associated with wholesale distribution and the Medicinal Products must have a Marketing Authorisation or authorisation for special use. |
|
|
The provisions to be complied with include the compulsory appointment of a technical director who shall effectively and permanently be the technical manager of the wholesale business. The technical director shall pursue his profession in Portugal and shall be a member of the Portuguese Society of Pharmacists. |
|
|
The technical director may work for one company only; otherwise he could not manage it effectively and permanently. |
|
|
This situation stems from article 102 of Decree-Law no. 48547 of 27 th August 1968 , and from article 4 (1) (d) and (2) (a), article 12 (1) (a), and article 15 (2) (a) of Decree-Law no. 135/95 of 9 th June , and from Administrative Rule no. 348/98 of 15 th June which approved good distribution practices. |
|
FEES
|
||
|
|
No. of Medicinal Products Cost Fee
|
|
What is the fee for Certificates or equivalent documents relating to Veterinary Medicinal Products? |
|
|
|
The fee laid down in no. 10 of the annex to Administrative Rule no. 377/2005 of 4th April shall apply to certificates and equivalent documents relating to both Medicinal Products for Veterinary and Human Use, because in both cases they are Medicinal Products regulated by INFARMED. |
|
||
|
|
The application, including the application letter and proof of payment of the €30 fee, should be lodged with the INFARMED general office. |
|
||
|
|
Active substance declarations may relate to more than one medicine and “Declarations relating to Medicinal Product MAs” refer to various MAs, and may even relate to different holders. In such cases the fee charged should be for ONE document issued. |
|
In the case of MA validity Declarations when the medicine file is being renewed, what is the fee? |
|
|
|
As regards MA validity Declarations, when the medicine is being renewed, the Declaration includes the expression “Valid for 3 (three) months, and it should be renewed when the medicine's MA renewal is granted.” Given that, under normal circumstances, such declarations are issued for a year, only the fee for the certificate valid for the first three months is payable and the updates for the next three quarters shall be free. |
|
What is the fee for “One Medicine Certificates” relating to Medicinal Products manufactured in Portugal , but without a MA? |
|
|
|
In these cases the fee laid down in no. 10 of the annex to Administrative Rule no. 377/2005 of 4th April shall apply. |