One of the important parts of the registration dossier for BMCP is the layout of the primary and secondary package ( Read more about the registration dossier by link ). Information, which must be written on the primary, secondary and transport package, is brought under regulation be the Order 145n.

1. According to the Order primary BMCP package should contain the following information:

– BMCP name

– BMCP trade name (if assigned)

– Type of BMCP (Read more about the types of BMCP by link )

–  Mode of administration and dosage frequency

– Manufacturing date and shelf life

 

2. The following information shall be present on the secondary (consumer) package:

– BMCP name

– BMCP trade name (if assigned)

– Type of BMCP

– Name of the pharmaceutical preparations included in the BMCP, as well as the date and number of their registration certificates (RC).

– Name of medical devices included in the composition of BMCP, as well as the date and number of their RC.

– Name of the RC holder, date and number of RC

– Name of the manufacturer of BMCP

–  Mode of administration and dosage frequency

– Manufacturing date and shelf life

– BMCP storage conditions

– BMCP Sterility data

3. The following information should be printed on the transport package for BMCP:

– BMCP name

– BMCP trade name (if assigned)

– Name of the RC holder, date and number of RC

– Name of the manufacturer of BMCP

–  Mode of administration and dosage frequency

– Manufacturing date and shelf life

The labeling of BMCP should be printed in Russian.

In addition to the aforementioned information, radio frequency identification should be provided for autologous and combined BMCP. The order of labeling of primary and secondary packages of such BMCP is regulated by the Order № 800 N.

What is radio frequency identification?

RFID – (Radio Frequency IDentification is a way of automatic identification of objects, intended for transmission by means of radio waves of the information necessary for identification (recognition), in this case BMCP, on which the radio frequency tags are fixed.

The information printed on the label with the radio frequency mark should correspond to the information encoded in the radi -frequency label itself.

The radio frequency mark should contain information about the BMCP belonging to a specific patient, as well as other information, individual for each product. The information encoded in this label must remain unchanged on all series, batches of this BMCP.

Radio frequency label for autologous and combined BMCP includes:

– Capital Letter A or C

– Via fraction –  the sequence number which is assigned in chronological order with the subsequent increase of number

– Via fraction –  number of RC.