Pakistan adopts drug barcode

Two D barcode has become mandatory in Pakistan for drug packs.

Back in February the Supreme Court had ordered the implementation of this new technology granting all concerned companies 3 months to implement all necessary measures to comply with the new obligation.

The barcode shall be included on the secondary packaging as well as on the immediate packaging (e.g. containers and bottles). This measure regards medicinal products for human use (including biologicals) as well as veterinary products.

Australia and UK seek trade agreement

The Australian government is looking for a new trade agreement with United Kingdom, in view of the future exit of UK from the European Union, which could mean new opportunities for investments for the former and a return to direct negotiations for the latter.

For the moment there were only unofficial talks, but both countries set up working groups, with meeting involving Prime Ministers as well. The agreement will focus on different aspects of the economy and industry of the two countries, such as pharmaceuticals, health and science.

A future deal could represent a great opportunity for the two countries, that could also involve a regulatory mutual recognition and more cooperation on investments, intellectual property, research and tax policies.

AIFA publishes new Pharmacovigilance FAQs

The Italian Medicine Agency has published a new FAQ document on the management of reports in the National Pharmacovigilance Network (RNF) to provide practical indications to pharmacovigilance responsible persons and facilitate the inclusion of the information reported in the ADR sheet and the performance of pharmacovigilance activities in the light of the changes following the provisions on the simplified electronic reporting of suspected adverse reactions.

In particular, the MAs are no more bound to ADRs reporting to local Pharmacovigilance responsible persons of the reporters’ health facilities or directly to the RNF, but they have to transmit them directly to the EudraVigilance, that will forward them to the RNF via “re-routing”.

The reporting of suspected ADRs by patients and/or health operators remain unvaried.

New use safety regulation for plant protection products

The Italian Ministry of Health has published Decree no. 33 of 22nd January 2018 (Regulation on the measures and requirements of plant protection products for a safe use by non professional users) on the Official Journal.

The decree includes the measures and requirements of plant protection products to prevent dangerous handling and ensure safe use by non professional users (the same user and all people that may come into direct or indirect contact with these products), during use or domestic storage. The decree also defines the requirements for the marketing and sale of these products.

Products complying with the decree and authorised for non professional use shall include the following wording on the label: “plant protection product intended for non professional users”. These products shall also include the acronyms PFnPO (for products to be used on ornamental plants in apartments, balconies and domestic gardens, and for the weeding of specific areas inside domestic gardens) or PFnPE (for products to be used on edible plants, intended for food consumption as whole plant or some of its parts and for the weeding of specific areas inside the cultivated area). The labels shall also include the crops and the further fields of use which the product is authorized for.

New OsSC platform

A new platform is about to be set up for the Italian monitoring body on drug clinical trials (Osservatorio Nazionale sulla Sperimentazione Clinica dei Farmaci – OsSC) and the Italian Medicine Agency has informed some useful information to all users.

In particular, the new OsSC platform requires that the PCs used for the access are equipped with a Smart Card for the signature including the relevant certificate, a Java Virtual Machine version 1.8x and a Browser Firefox ESR for the digital signature. However, it will be possible to navigate the system also with all other main browsers (except for Internet Explorer) and not for the digital signature.

The new platform will be released after 16th May.

US prepares for unique code for devices

The US Regulatory Agency FDA is preparing all the required information in view of the adoption of the unique code for medical devices and the relevant database (GUDID – Unique Device Identification Database).

The information to be published within summer, will support the registrations of medical devices. The US Agency has recommended that companies check the data to be included in the GUDID contain all the registration numbers required and that he name of the devices in the database are complete.

As for the timetable, the database should be ready for next May, but registrants must control all data before it becomes public.

EMA redistributes UK DCP portfolio

In view of the Brexit, the European Medicine Agency has redistributed the portfolio of the medicinal product for human and veterinary use authorized at central level sharing more than 350 products currently managed by British agencies to rapporteurs and co-rapporteurs of other countries.

At the moment, the staff of the British regulatory Agency (MHRA) and Veterinary Medicines Directorate (VMD) have a leading role in the assessments and processes related to the European Centralized Procedure, however after Brexit it will be no more possible for them to cover such role. The products have been therefore re-assigned to other 27 Member States and to Island and Norway, who took full responsibility of the products starting from last 30 March.