FAQ

Pharmaceutical regulations change very often and pose new requirements on both existing and new pharmaceutical products. In this section, we have answered a list of typical questions. Please contact us for more information.

What methodology is used for a consultation with patients regarding the package information leaflet?

The testing methodology was based on a formulation originally developed in Australia in the 1990s. The guidance was taken directly from EMEA and since the beginning of the requirement, it has developed to include feedback and interpretations from member states responsible for assessing the testing and reporting. The testing we perform has been accepted by all member states in the EU as either a RMS or CMS. Due to the procedures, we believe all member states have reviewed the testing at some stage.

The most active competent authorities for Readability Testing and developing the methodology and reporting process have been the MHRA, MEB and AFSSAPS. The testing and reporting has been developed to be accepted by all member states.

Click here for more information on Pharma-EU PIL User Test Methodology

How many potential patients are required to be tested for a readability study? What are the inclusion and exclusion criteria? How are they recruited?

A complete test normally requires 23-25 participants. The testing includes 3 stages, 3-5 participants for the preliminary testing and 2 rounds on 10 participants.

Participants selected for testing general inclusions:

are people who do not use written documentation at work
are people who speak English (or target language) as their first language
are over the age of 18 years
have at the minimum attended primary school and at the maximum had 4 years of university studies.

Participants selected for testing general exclusions. People who:

work in the medical, pharmaceutical, advertising or media professions
have moral or religious objections to taking medicines
have attended university for more than 4 years
have participated in PIL readability testing in the past
are currently taking this medicine.

Which health agencies have accepted your readability tests?

Pharma-EU branded readability tests have been accepted by all agencies in the EU. The MHRA has approved over 200 tests to date and AFSSAPS have approved over 50. The testing has been performed and assessed for numerous procedures including the UK patient information quality initiative as well as for French patient information quality initiatives. Testing is routinely performed to support PILs for National Procedures, MRPs, DCPs and CPs.

We have 100% acceptance to date. No tests have ever been denied.

What languages can you perform the testing in?

The most common languages for testing have been English, Swedish, French and German. For mutual recognition procedures, decentralised procedures, and centralised procedures we recommend the testing to be performed in English or the RMS language if the UK will not be involved in the procedure.

For national requirements, it is necessary to test in the national language. We know that the UK, Ireland, Sweden, France, Portugal, Spain and Germany have been enforcing this requirement.

For most testing, the results are reported in English. The only exception to this rule is French national PILs being tested in French. This testing is reported in the French language.

Click here for complete overview of all European languages in which we currently provide PIL user testing.

How long does a readability test take to complete? How long for a bridging study to be prepared?

A readability study usually takes 4 weeks to be completed. They can be performed in as little as 2 weeks if the situation is urgent. Testing is routinely performed during clock stops of DCPs and be expedited.

Bridging studies can be prepared in a few days.

Which PILs can be bridged?

This is a tough question and has a lot of exceptions to the rule. Generally, PILs having the same indications and active ingredients should be fit for bridging. This is not always the case, as we have found that identical active ingredients may have quite different messages in the PIL for different MA holders.

We recommend you to send us the PILs you would like to bridge for a case by case analysis.

It also depends upon which competent authorities will be assessing the bridging. Certain member states are much more stringent in assessing bridging and readability.

Do you have a protocol you can send us for the testing?

Yes, an example of this can be sent upon request. Different clients prefer to arrange different ways of working varying from us writing the PIL and having the Mock Up created.

How many readability tests have you performed?

Over 600 as of October 2008.

Can you arrange for Decentralised Procedure slots in 2009?

Yes, but we will need to have a contract in place to represent your company to secure it.

FAQ