Monday, 13 February 2012

What about some "Regulatory affairs in the US and EU" - Part VI of X

Preface: I have got to apologise to those who've been involved in reading about the regulatory affairs course I took but in my defence I have an arrogant influenza virus that decided to live on my expenses for nearly 2 weeks. Only today I can assume that I feel at around 96%, where the remaining 4% was given to the coughing mode. Well, let's not delay this sixth module review because there's plenty to learn and plenty to assess. Once again, thanks for joining me in this quest, I hope this piece of information can be of good use for you guys.

What is reviewed in the sixth module? Immediately as you start reading there are some good pages covering over-the-counter products, the origin of such label, differences when compared to the prescription only pharmaceuticals. Also the legislation that runs these same products is reviewed by the author. In addition, there are news on the alternative medicines (herbals and homeopathics) front, not only in terms of popularity but also the most important legislation and market growth.

What about funny and curious facts revealed in this module? The concept of switching, I was totally unaware of, i.e., making a prescription only medicine a pharmacy only or even be added to the general sales list. I didn't know that in the European Union only in the United Kingdom and Ireland you could find over-the-counter products being sold in general retail outlets, however I believe that is about to change soon, as many other countries are discussing that some possibility to be introduced sooner than later.

"Advice on the format of expert reports can be found in Volume IIB of the Notice to Applicants for Marketing Authorisations for Medicinal Products for Human Use in the Member States of the European Community" - wow!, this is big...

I just loved the reference to "Avoid alcohol if you are taking antihistamines, cough-cold products with the ingredient dextromethorphan, or drugs that treat sleeplessness" because I adore practical information that can be used in the quotidian. The drug interactions part was a short and merely informative curious bit, but I quite liked it.

What about some awesome quality information? In 2001 the Medicines and Health Care Products Regulatory Agency presented one of the most wanted measures concerning the industry of the over-the-counter's trying to encourage companies to switch more and more medicines from prescription only label to the pharmacy one; also a label for the blind people was added to the boxes and a few more interesting things.

‘Rx-to-OTC switching’ is how our fellow Americans call the process of legal reclassification of medicines for over-the-counter use.

I believe that the example given of an EU herbal medicines registration scheme and the Herbals and herbal components under study by the national toxicological programme is very good because it gives an idea of practicality for all the information acquired so far.

Is there anything missing? This is a very concise and succinct module but one can see all the pertinent information is there. I can't hardly find anything missing. The way it's written is quite intelligent and pleasant for the reader to go through. Having said that, and just to make the course a little more complete, I would attach to the documents of the course some printouts/handouts/digital pages of the many directives and pieces of legislation stated throughout the course. That would help a big lot!

Image taken from National Pharmacy Technician Association, [], last visited on the 13th of February 2012, last updated unknown.

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