Consultation Document on the Amendment to Legal Notice 437 of 2004 – Parallel Importation of Medicinal products Regulations
Published 2nd April 2014
The Medicines Authority invited the Malta Chamber of Pharmacists to make its comments re the attached Consultation Document on the Amendment to Legal Notice 437 of 2004 – Parallel Importation of Medicinal products Regulations.
The Chamber in turn forwarded its comments in an email to the Medicines Authority on Saturday 29th March.
“We have reviewed the document and would like to bring to your attention the lack of reference to the pharmacovigilance obligation of the parallel importer. Thus, we recommend that, at:
Art 4(2) A further clause should be added to provide for the inclusion of a summary of the applicant’s pharmacovigilance system to reflect the applicant’s obligations w.r.t. the products placed on the market.
Art 7 – This article should include: an additional para., entrenching the parallel importer’s duty to operate a pharmacovigilance system as per Title IX of Directive 2001/83/EC; and an additional para., in accordance with Art 76 Para 3 of the Directive, on the obligation of the PI, in the event of repackaging, to provide the Medicines Authority with a written declaration which states that the MAH has been informed of the intent to import a particular product or products (together with a copy of the letter). “
To view the Consultation Document please click below:
Consultation Document on Amendments to Parallel Importation Regulations
draft_pi_ln_consultation_fnlv3-parallel-imports-medicines-authority
23rd April 2012
The Medicines Authority has invited the Kamra ta’ l-Ispizjara ta’ Malta and other stakeholders to give thier views on three (3) important consultation documents. As a member of the Kamra you are invited to send us your comments on either one or all of the documents by the respective deadlines:
1.Consultation Document on the amendment to Legal Notice 315 of 2006 – Medicines Authority (fees) Regulations, 2006, as regards fees related to product registration activities where malta is reference member state in the european procedures (Mutual Recognition and Decentralised Procedure)
Medicines Authority_Fees LN_Consultation_FNL
Comments are to reach us in writing via the comments field on the website or via e-mail on info@spizjara.org by not later than Monday 7th May 2012.
2. Consultation Document on implementation of Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use.
Comments are to reach us in writing via the comments field on the website or via e-mail on info@spizjara.org by not later than Wednesday 23rd May 2012.
3. Consultation Document on the proposed amendments to Subsidiary Legislation 458.16 (Legal Notice 279 of 2007 as amended (Pharmacy Licence Regulations, 2007) and to Subsidiary Legislation 458.49 (Legal Notice 292 of 2006 – Prescription and Dispensing Requirements Rules).
Medicines Authority_Prescriptions LN Consultation_FNL
Comments are to reach us in writing via the comments field on the website or via e-mail on info@spizjara.org by not later than Monday 10th June 2012.