DIA Global Regulatory Activity Digest - Drug Information Association

This form is to be filled to apply for the renewal of the marketing authorization of medicinal products
whose current MA expires by the end of 2005.
GREECE - Form for the Withdrawal of the Packaging of a Pharmaceutical Product, Sep-2005
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format.
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This form is to be filled in by the applicant who wishes to withdraw the packaging of a pharmaceutical
product.
IRELAND
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IRELAND - IMB: Important safety notice: Concerning Ayurvedic Medicinal Products found to
contain High Levels of Heavy Metals, 18-Aug-2005
The Irish Medicines Board (IMB) has recently learned that specific Ayurvedic medicinal products have
been found to contain high levels of heavy metals such as mercury, arsenic and lead, in the United
States. The products concerned are shown in the table in the document.
JAPAN
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JAPAN - PAB Notification No. 725: Enforcement of the Law for Partial Revision of the
Pharmaceutical Affairs Law and the Adverse Drug Reaction Sufferings Relief Fund Law, 25-
Aug-1993
This document announces the matters implemented by the enforcement of the Law for Partial Revision of
the Pharmaceutical Affairs Law and the Adverse Drug Reaction Sufferings Relief Fund Law (Law No. 27 in
1993) The first section covers on priority evaluation and re-examination period. The definition of the
product which is applied to the re-examination, the period and the outline of the re-examination are
described. The second sections covers orphan medicinal product and orphan medical device designations.
It describes the scope of orphan medicinal product and explains the application. The relevant application
forms are included.
The revisions of this document have been made. The last amendment is refered in PMSB Notification No.
1324, 27 December 2000 (32564).
PORTUGAL
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PORTUGAL - Decree-Law 129/2005: Modification and Re-publication of the Decree-Law
118/92 of 25-Jun-1992, 11-Aug-2005
This Decree-Law modifies the articles 2 and 3 of the Decree-Law 118/92 (26093) laying down the
reimbursement regimen by the State of the price of medicinal products.
As a result of the government measures taken in the framework of health reforms and following the
publication of the Ministerial Order 618-A/2005 (52727) setting up a 6% reduction in the price of the
reimbursable medicinal products, this Decree-Law 129/2005 determines that the Scale A of the State
reimbursement will be at 95% of the public price (PVP) of medicinal products. Special situations are also
regulated in this Decree-Law.