Introduction
The Inspectorate and Enforcement Directorate is a key
Directorate within the Medicines Authority which, as detailed
in the Medicines Act 2003, is responsible for:
1. The
inspection and licensing of the manufacture, distribution and
sale of medicinal products. Active Pharmaceutical Ingredients
(API`s) will also fall within the portfolio of the Directorate
as from October 2005.
2.
The inspection and licensing of public and retail
pharmacies.
3. The
certification for export and issue of certificates of
Pharmaceutical Products and GMP certificates for locally
manufactured medicinal products
4.
The provision of advice to the Licensing Authority in
relation to the activities falling within its remit
5.
The enforcement of standards and the provisions of the
Medicines Act 2003.
Staff complement
The Directorate staff complement comprises a Director, five
Inspectors and an administrator.
Activities
The activities of the Directorate mainly include:
1. The
inspection of the various pharmaceutical activities including
a) manufacture of finished dosage forms, API`s, and investigational medicinal products for use in clinical trials
b) importation c) wholesale dealing d) partial
manufacture/assembly and e) pharmacies, and to verify
compliance with GxP standards as stipulated in the Medicines
Act 2003 and EU Directives.
2.
The licensing of the above mentioned pharmaceutical
activities.
3.
Monitoring of GxP standards during the licence period.
4.
The provision of export certificates to local
manufacturers for medicinal products.
5.
The market surveillance and enforcement of regulations
and standards as part of the
inspection and follow-up process.
6. The
management of a product defect reporting system and
coordinating all product recalls
7. Investigation
of possible breaches of legislation relating to unauthorised manufacture, importation, wholesale dealing, advertising,
marketing of medicinal products, and or breaches of marketing authorisations or other licenses. These duties are discharged
as part of the enforcement activities.
EU
Legislation
Maltese
Legislation
Inspections
Inspections are carried out by
Medicines Inspectors of the Authority in order to assess
compliance with the provisions of the Medicines Act 2003 as
well as
EU standards relating to the specific activity. Inspections
are always performed when a new application is received. Upon
the outcome of the inspection findings a licence can be
recommended or rejected. Routine follow-up inspections are
also carried out. Surprise inspections may be warranted in
specific circumstances or following a complaint.
Inspections constitute a major activity
within the Directorate and are considered as being crucial in
ascertaining that the conditions of the licence are met.
GMP
and GDP Inspections
These inspections are aimed at
establishing the compliance, or otherwise, with GMP and GDP
requirements and standards as laid down in the Medicines Act
2003 and EU legislation..
http://www.emea.eu.int
http://www.emea.eu.int/inspections/index.html
http://dg3.eudra.org/F2/eudralex/vol-4/home.htm
http://dg3.eudra.org/F2/pharmacos/docs/Doc2001/may/GDPGuidelines1.pdf
http://www.emea.eu.int/Inspections/WhatsNew.html
Pharmacy Inspections
Pharmacy Standards -
Pharmacy
inspections are aimed at verifying that the conditions and
standards as laid down in the Medicines Act 2003 are met.
Pharmacies in Malta/Roster
List of Pharmacies in Malta
Legal classification status of medicines - The legal
classification status of medicines will be assigned as part of
the Marketing Authorisation for each specific product.
Licensing
Licenses for the various pharmaceutical
activities are issued upon establishing that the relevant GxP
requirements and provisions of the Medicines Act are achieved.
If during the licence period it results that the standards of
good practice are not met or that any other provision of the
Medicines Act is not abided to the licence can be revoked,
suspended or varied.
Application for a Certificate of GMP Compliance of a
Manufacturer
Revised - 21/12/04
Guidance note regarding Medicinal Product Defect
Reporting - 18/01/06
Medicinal Product Defect Reporting Form
- 18/01/06
Certification
Applications may be received for the
issue of CPP`s and GMP certificates. The guidelines of the WHO
and EU are followed when issuing such documentation.
Application for a
Certificate of a Pharmaceutical Product -
Revised 15/09/04
Product Defect Reporting
In order to protect public health,
market authorisation holders are required to notify the
Medicines Authority of any quality defect in respect of their
products. Upon verifying the information received the
Authority may recommend a batch recall or restriction of
supplies from the distribution chain.
The Authority can also receive
notification of product defects from other competent
authorities, the medical profession, wholesalers, pharmacies
and patients.
Suspected or obvious batch defects can
be reported by mail, email, fax or telephone :
By Mail - The Medicines
Authority
198, Rue D`Argens, Gzira
By Email -
By Phone –
00356 23439000
By Fax – 00356 23439161
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Recalls
Pulmicort 200
microgram/dose pMDI (Class II Medicines Recall)
03/11/2004
Diclogesic
12.5mg Suppositories (Class II Medicines Recall)
12/08/2004
Amsidine
75mg ampoules, solution for infusion (Class 2 Medicines Recall)
03/06/2004
Qualified Persons
Qualified
Person (QP) Eligibility Interviews 4th-7th May 2004
Inspectorate events
Seminar
- The Role of the Qualified Person in the Regulation of Medicines for Human
use.
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