Update of product information

The marketing authorization holder (MAH) for a medical product is responsible for updating the product information in relation to new knowledge or recommendations.

It is also the responsibility of the MAH to, on a regular basis, cover present sources and to implement changes without reminder. On this website the Medical Product Agency (MPA) has gathered information and links to facilitate the monitoring of changes that need to be done.

CMDh press release


CMDh assembles once a month and some week later a press release is published that summarizes the discussions and decisions.
 CMDh press releases

PRAC recommendations on safety signals


Once a month, after the PRAC meeting, all PRAC recommendations on safety signals that have been discussed are published. Here you can also find an accumulated list with information on all signal assessments.

The product information is translated into all official European (EU) languages. The translations are published shortly after the English translation has been published.
 PRAC recommendations on safety signals

Referrals

 
Here you can find information on ongoing as well as finalized referrals. The MAHs concerned by a procedure will be informed by EMA.
 Referrals – human
 Referrals - veterinary

Referrals - decisions

 

Under the headline ”Procedures for nationally authorized medicinal products” you will find decisions from the EU commission regarding referrals.
 Referrals - decisions

PSUR Summaries of Assessment Reports after PSUR Work sharing

 
CMDh lists substance summaries of assessment reports in alphabetical order. The list is updated when a PSUR-procedure is completed. 
 Summaries of Assessment Reports

PSUSA – centrally approved Products

 

EMA communicates directly with all MAHs that have been included in a PSUSA CAP. MAH for generic products monitor the publication of the result themselves in the EU commission´s Community register. For centrally approved products EMA handles the implementation in connection with current PSUSA.
 Pharmaceuticals - Community Register

PSUSA – nationally approved products


Here we publish the result from PSUSA for nationally approved products.
 Pharmaceuticals - Community Register

Paediatric Worksharing


HMA (Heads of medicines agencies)/CMDh publishes information of the result of Paediatric Work Sharing-procedures. The websites are being updated consecutively.
 Assessment Reports on Paediatric Data

Request regarding Post authorisation Control of a Medicinal Product


The MPA supervises that MAH update their product information within dictated time through random controls. In case of deviation, the MPA will send a request regarding Post authorization Control of a Medicinal Product to MAH/local representative with demands on update. Avoiding answering to such a request might result in an injunction and in the prolongation consequences such as deregistration of the product.

A request regarding Post authorization Control of a Medicinal Product will also be sent when the internal MPA assessors discover, or are being noticed on, faults or deficiencies only valid nationally,   i.e. mistranslation in the SmPC and request for childproof packaging.

The requests regarding Post authorization Control of a Medicinal Product sent in the last year are here being published in de-identified form.
 Request regarding Post authorisation Control of a Medicinal Product

 
 
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information