Labeling of drugs is liable to strict regulations. Text templates for package leaflets and SmPCs given by the BfArM have to be considered. In addition, QRD (Quality Review of Documents) guideline of the EMA requires compliance.

Labeling Compliance is one of the core competence of MedPharmTec^®.
Our experienced employees provide support for:

• Care of SmPC
• Preparation and Care of QRD
• Supervision of Red List, Yellow List and obligatory texts
• Readability tests
• Management of Duplicates
• Red List Information service for Patients
• Labip (Labeling inner pack) and Labop (Labeling outer pack)

 

Details of our Labeling Compliance Service:

For an approved product  there is the possibility to apply for (new) authorization  to secure it (duplicate registration). Every change made in the original marketing authorization have to be adopted in all duplicates.

We provide a document management service for your duplicates.

 

With the entry into force of the 14^th AMG Amendment (§11 Abs. 3c) drug manufacturers have the legal obligation to provide product informations also for blind and visually impaired persons (e.g. audio files, large prints).

For your participation in the Patient Information Service of the red list we provide the following services:

• Editing of the product informations according to the guideline of the red-list Patient Information Service.
• Review and updating of your product informations.

For SmPCs, perfect and error-free texts are essentiell to avoid expensive recalls.

MedPharmTec^® offers you the following services with the preparation of SmPCs:

• care and review for SmPC texts
• review of the SmPC plaintext with print version incl. coordination with the printery
  
   

For package leaflets, the preparation of correct and faultless texts are essentiell to avoid expensive recalls.

MedPharmTec^® provides support and prepares your text documents according to conventions/templates of the QRD (Quality Review of Documents)-Group of the CHMP. Readability as well as national guidelines receive attention. As a result you get a QRD conform document.
 

MedPharmTec^® offers the following services concerning the supervision of master sheets for the Red List, Yellow List and obligatory texts according to the Health-related Products and Services Advertising Act (HWG):

• changing of master sheets or automated linking with changes in the SmPC
• complete or partial restatement of text for the master sheets 
• full project coordination with the editorial office of the publishers until the text is perfect
  
   

For the package leaflet of approved pharmaceuticals a readability test is required by law since 2006. To control the comprehensibility of the package leaflet an interview with a target group is performed. For a clear understandable package leaflet, 90 % of the participants have to find the requested information and 90 % thereof have to understand it.

We offer the following services:

• preparing the protocol and the questionnaire for the target group survey

• performing the readability test using interview procedure