Federal agency for medicines and health products
Responsible for Information and Publicity
Josiane Van der Elst
Director General Inspection
BRAS meeting 9
th
of December 2014
Table of contents
1.
Legal Context
2. Obligation of the Marketing Autorisation Holder
3. Functions and duties of the Responsible for
Information and Publicity
4.
Granting of an agreement number as RIP
1. Legal Context
•
The Directive 2001/83/EC of the European Parliament and of
the Council of 6/11/2001 on the Community Code relating to
Medicinal Products For Human
Use, article 98.
•
The Law on the medicinal products of 25/03/1964, article 9.
•
The Royal Decree related to the information and advertising for
human use medicinal products of 07/04/1995, articles 11, 13,
14, 15, 17 & 18.
2. Obligation of the MAH (1)
The Marketing Authorisation Holder must appoint a person
responsible for information and publicity (RIP).
The MAH must communicate the name of the RIP to the
FAMHP (he can be member of the company or a consultant).
Any change must be notified to the FAMHP
When the RIP is absent (illness, vacation,…), his replacement
must be notified to the FAMHP.
Only O
NE
RIP by MAH.
2. Obligation of the MAH (2)
The assignment of a Responsible for Information and Publicity
must be sent by postal mail to
Chantal Lambrechts
(
Chantal.Lambrechts@fagg-afmps.be
)
F
ederal
A
gency for
M
edicines and
H
ealth
P
roducts
EUROSTATION building, block 2
place Victor Horta, 40/ 40
1060 Brussels
In this letter to the FAMHP the company must communicate the
name, agreement number and start date of the RIP.
This statement must be signed by the General Manager of the
MAH and the assigned RIP.
3. Functions and duties of the Responsible
for Information and Publicity (1)
Responsibilities of the RIP include:
•
Verification of the compliance of the SPC, the leaflets and their
translations
Must sign the « Declaration of Conformity » for registration
of variations on a marketing authorization (OZB 469).
•
Gives final approval on advertising projects
•
Oversees the training of medicinal representatives who visit
doctors, pharmacists and other healthcare professionals.
3. Functions and duties of the Responsible
for Information and Publicity (2)
•
Ensures
compliances of regulations on « samples »
(RD 11/01/1993 on fixing the conditions in which the delivery of medicines for
human use in the form of samples can be made)
•
Establishes an appropriate internal procedure for approving
advertising and various promotional activities
•
Responsible for the information provided by his company ( ex.:
questions from patients, professionals,…)
•
Ensures compliance of regulations on « premiums or
advantages »
(RD 07/04/1995 on the information and publicity concerning human medicines,
articles13 § 4, 15 and Law of 25/03/1964 on Medicines, article 10)
4. Granting of an agreement number as
RIP (1)
Conditions:
•
Holder of a legal diploma of pharmacist, doctor or veterinarian
•
The EC nationals, holders of an equivalent diploma can also be
approved as RIP with a EU/EEA recognition of his professional title.
The Request for recognition EU/EEA professional title must be
obtained from the Unit of International Mobility of Healthcare
Professionals, FPS Public Health, Directorate General Primary
Healthcare and Crisis Management.
•
Justification of an experience of at least one year in the field of the
pharmaceutical information (veterinarians: 5 years before
29/08/1984 – RD 07/04/1995, article 13)
4. Granting of an agreement number as
RIP (2)
•
The file to be introduced must contain the following documents:
1.
A personal request
2.
Curriculum Vitae
3.
A copy of the diploma of pharmacist, doctor or veterinarian
4.
A justification of at least one year of experience in the field of
the pharmaceutical information by the presentation of
descriptive certificate of the accomplished tasks. This
certificate is delivered by the General Manager of the company
in which this experience was acquired or a RIP who has an
agreement number since more than one year.
4. Granting of an agreement number as
RIP (3)
All these documents (including personal request) have to be
sent
by postal mail
to the following address :
(
Chantal Lambrechts
–
Chantal.Lambrechts@fagg-afmps@be
)
F
ederal
A
gency for
M
edicines and
H
ealth
P
roducts
EUROSTATION building, block 2
place Victor Horta, 40/ 40
1060 Brussels
Personal
contact details (address, phone number, email) are
required.
4. Granting of an agreement number as
RIP (4)
If the conditions are fulfilled:
•
An agreement number is communicated by post to the personal
address of the applicant.
•
The agreement is published in the Belgian Monitor (annual
publication)
The agreement number is personal. It is not linked to a company.
A RIP can work for different companies.
The agreement number is valid during the career of the person
except when this person is the object of a procedure of
suspension or of withdrawal of his agreement.
Federal agency for medicines and health products - famhp
Place Victor Horta 40/40
1060 Bruxelles
tel.
0032 2 524 80 00
fax
0032 2 524 80 01
welcome@fagg-afmps.be
Central point of contact RIP
Chantal.Lambrechts@fagg-afmps.be
www.afmps.be
Contact
Here is information regarding the legal context, obligations, functions, and duties of the Responsible for Information and Publicity at the Federal Agency for Medicines and Health Products. It covers directives, laws, and requirements related to medicinal products in the European Union.
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Presentation Transcript
Federal agency for medicines and health products Responsible for Information and Publicity Josiane Van der Elst Director General Inspection BRAS meeting 9thof December 2014
Table of contents 1. Legal Context 2. Obligation of the Marketing Autorisation Holder 3. Functions and duties of the Responsible for Information and Publicity 4. Granting of an agreement number as RIP Date Subject famhp/entity/Division-Unit-Cell 2
1. Legal Context The Directive 2001/83/EC of the European Parliament and of the Council of 6/11/2001 on the Community Code relating to Medicinal Products For Human Use, article 98. The Law on the medicinal products of 25/03/1964, article 9. The Royal Decree related to the information and advertising for human use medicinal products of 07/04/1995, articles 11, 13, 14, 15, 17 & 18. Date Subject famhp/entity/Division-Unit-Cell 3
2. Obligation of the MAH (1) The Marketing Authorisation Holder must appoint a person responsible for information and publicity (RIP). The MAH must communicate the name of the RIP to the FAMHP (he can be member of the company or a consultant). Any change must be notified to the FAMHP When the RIP is absent (illness, vacation, ), his replacement must be notified to the FAMHP. Only ONE RIP by MAH. Date Subject famhp/entity/Division-Unit-Cell 4
2. Obligation of the MAH (2) The assignment of a Responsible for Information and Publicity must be sent by postal mail to Chantal Lambrechts (Chantal.Lambrechts@fagg-afmps.be) Federal Agency for Medicines and Health Products EUROSTATION building, block 2 place Victor Horta, 40/ 40 1060 Brussels In this letter to the FAMHP the company must communicate the name, agreement number and start date of the RIP. This statement must be signed by the General Manager of the MAH and the assigned RIP. Date Subject famhp/entity/Division-Unit-Cell 5
3. Functions and duties of the Responsible for Information and Publicity (1) Responsibilities of the RIP include: Verification of the compliance of the SPC, the leaflets and their translations Must sign the Declaration of Conformity for registration of variations on a marketing authorization (OZB 469). Gives final approval on advertising projects Oversees the training of medicinal representatives who visit doctors, pharmacists and other healthcare professionals. Date Subject famhp/entity/Division-Unit-Cell 6
3. Functions and duties of the Responsible for Information and Publicity (2) Ensures compliances of regulations on samples (RD 11/01/1993 on fixing the conditions in which the delivery of medicines for human use in the form of samples can be made) Establishes an appropriate internal procedure for approving advertising and various promotional activities Responsible for the information provided by his company ( ex.: questions from patients, professionals, ) Ensures compliance of regulations on premiums or advantages (RD 07/04/1995 on the information and publicity concerning human medicines, articles13 4, 15 and Law of 25/03/1964 on Medicines, article 10) Date Subject famhp/entity/Division-Unit-Cell 7
4. Granting of an agreement number as RIP (1) Conditions: Holder of a legal diploma of pharmacist, doctor or veterinarian The EC nationals, holders of an equivalent diploma can also be approved as RIP with a EU/EEA recognition of his professional title. The Request for recognition EU/EEA professional title must be obtained from the Unit of International Mobility of Healthcare Professionals, FPS Public Health, Healthcare and Crisis Management. Directorate General Primary Justification of an experience of at least one year in the field of the pharmaceutical information (veterinarians: 29/08/1984 RD 07/04/1995, article 13) 5 years before Date Subject famhp/entity/Division-Unit-Cell 8
4. Granting of an agreement number as RIP (2) The file to be introduced must contain the following documents: 1. A personal request 2. Curriculum Vitae 3. A copy of the diploma of pharmacist, doctor or veterinarian 4. A justification of at least one year of experience in the field of the pharmaceutical information by the presentation of descriptive certificate of the accomplished tasks. This certificate is delivered by the General Manager of the company in which this experience was acquired or a RIP who has an agreement number since more than one year. Date Subject famhp/entity/Division-Unit-Cell 9
4. Granting of an agreement number as RIP (3) All these documents (including personal request) have to be sent by postal mail to the following address : (Chantal Lambrechts Chantal.Lambrechts@fagg-afmps@be) Federal Agency for Medicines and Health Products EUROSTATION building, block 2 place Victor Horta, 40/ 40 1060 Brussels Personal contact details (address, phone number, email) are required. Date 10 Subject famhp/entity/Division-Unit-Cell
4. Granting of an agreement number as RIP (4) If the conditions are fulfilled: An agreement number is communicated by post to the personal address of the applicant. The agreement is published in the Belgian Monitor (annual publication) The agreement number is personal. It is not linked to a company. A RIP can work for different companies. The agreement number is valid during the career of the person except when this person is the object of a procedure of suspension or of withdrawal of his agreement. Date 11 Subject famhp/entity/Division-Unit-Cell
Contact Federal agency for medicines and health products - famhp Place Victor Horta 40/40 1060 Bruxelles tel. fax 0032 2 524 80 00 0032 2 524 80 01 e-mail welcome@fagg-afmps.be Central point of contact RIP Chantal.Lambrechts@fagg-afmps.be www.afmps.be Date 12 Subject famhp/entity/Division-Unit-Cell
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