Blog
Can we speed up drug Administration without affecting patient safety?
Analyses have shown the US Food and Drug Administration gets drugs to the market faster than other major regulators but it is still too slow. Can approvals be achieved quicker without affecting patient safety? Some companies took years to submit their...
EXPORTERS BEWARE
If you Export from the UK, have you kept up with the current requirements of GDP? Do you know what the MHRA will expect of you at your next inspection? Do you do the following: Use “EXW” Incoterms? Do you check if the products your customer has collected have been...
Stop taking Antibiotics when you feel better not at the end of the course?
Changes often bring surprises and they need to be risk assessed. This new guidance is in direct conflict with what I have told patients for the thirty years that I have been qualified. When I first qualified the message was pre-printed on labels which we religiously...
QOFXIT are QOFs days numbered
Cries for “QOFXIT” are being heard from the Government and BMA in the same way as people called for Brexit. There is of course a lot of people who would agree, but it would be good to see as full risk assessment of the pros and cons if we have a QOFXIT and a detailed...
Dermal fillers may become Prescription Only – What do you think ?
The Nuffield Council on Bioethics recommends that dermal fillers become prescription only. This would mean that they would not be able to be advertised in line with other prescription only medicines. Currently many prescribers order their fillers on prescription,...
Clean Backups, Robust Firewalls, Patch Updates, tightly managed passwords, and access privileges, do you have all of these?
The MHRA have been issuing majors to pharmaceutical wholesalers for several years if they do not have a backup procedure and there is no evidence of it being tested. Loss of data may result in a critical finding if it cannot be produced during an inspection. Why do...
Is your medical equipment vulnerable to a cyberattack? You better find out.
Is the software embedded in your medical equipment vulnerable to a cyberattack? Equipment running older software is much more vulnerable to cyberattack. Older software may be embedded in medical devices and may require regular updates. Find out if it is possible?...
Seven useful terms explained for new wholesalers who want to Export medicines out of the EEA.
Seven useful terms: “IATA” “The International Air Transport Association “this body regulates air travel worldwide. IATA are responsible for security and safety of air travel and the regulation of air transport of dangerous goods. “CEIV “Centre of Excellence for...
Contracting a Consultant is only half the battle!
Quality Management Systems (QMS) for Wholesalers can be built by a consultant alone, but the best QMS is one which has input from the Company, the staff who carry out the activities and the managers who are responsible for the business and specific processes within...
The UK may see medicine shortages and delays in the introduction of new medicines after Brexit.
The EU market accounts for 25% of all global medicines sales, when we break away and become a smaller separate market, companies may very well priorities bigger markets to introduce their medicines into over the UK. The NHS may as a result struggle to access...
Centrally authorised Medicinal Products for Human and Veterinary Use
The UK triggered Article 50 of the Treaty on European Union on 29th of March 2017 and as a result all primary and secondary law ceases to apply to the UK from 30th of March 2019. Companies who hold centrally authorised “MA s” must proactively review their MA terms,...
Who do you turn to for your PGDs now?
I read with interest that the largest suppliers of PGDs has folded with immediate effect. They have trained over 2000 people, and issued certificates of PGD service provision. This is begging the question why? Have they fallen fowl of CQC? Have they gone into...