SmPCs

Summary of Product Characteristics (SmPC) (for products with marketing authorisation in the Community)... 

The first of these can be used when a product is to be marketed in a single country. It can be used for any type of application except for certain types of biotechnology-based items. Having been approved in one country, in most cases an application to a second country will trigger the Mutual Recognition procedure in other concerned countries. There are certain exceptions to this, e.g., where a product has different summaries of product characteristics (SmPCs) in different countries, and these have not been subjected to a harmonization procedure. Line extensions to such products could also remain subject to national procedures. 

One outcome from fertility studies that requires additional investigation is an effect in a combined fertility study i.e., one in which dosed males are mated with dosed females. To permit full assessment of the potential risks to patients, it should be determined which gender is affected, or whether both are susceptible. Depending on the type of product, the absence of such knowledge need not necessarily preclude the grant of a marketing authorization, but the absence of information would need to be disclosed in the SmPC. 

Justification for suggestions for Sections 4.6 and 5.3 of the SmPC should be included. 

These guidance documents can be read in full and the details will not be reproduced here. They should be consulted before the SmPC is drafted and the guidance followed. The first gives the overall layout of the SmPC and lists the salient points from data on reproduction to be included in Sections 4.6 and 5.3. 

For reproductive toxicologists, the most relevant sections of the SmPC are 4.6 and 5.3, and Section 4.3 ifit is deemed necessary to contraindicate the product in pregnancy. Sections 4.4 and 4.5... 

As more clinical data on pregnancy, lactation, and fertility become available, it might be necessary for the SmPC to be updated if sufficient numbers of women have been exposed to permit a more accurate estimate of any risks, or to demonstrate an absence of risk. 

Medicines Compendium. http //www.medicines. org.uk/emc/medicine/ 691 / SmPC/ Differin-t Cream/... 

In our discussion of SMPC circuits, the switching method has been assumed to be hard switching. In hard switching, the current and voltage stresses imposed on the switches and diodes are not considered (or minimized) by the control electronics. The duty cycle or frequency of the system is adjusted solely to maintain the required output voltage, current, or power. Switching losses in these systems can be quite high. 

Silicon diodes used as output rectifiers in SMPC circuits also contribute to power loss. As the diodes switch between the forward- and reverse-biased states, a... 

V-methyl-V-phen-ylcarbamoyl-sulfanyl (SMpc) CXxsA Me reducing agents HF R SH, specifically DTT or pyridine-2-thiol... 

Methoxycarbonylsulfenyl chloride (SMoc-Q)P is a valuable reagent for the synthesis of asynunetric disulfides via reasonably stable, isolable 5-(methoxycarbonylsulfanyl) derivatives. This procedure has been successfully transferred to cysteine peptides for selective intrachain and interchain disulfide formation (see Vol.E22b, Section 6.1.3.1). Due to the high reactivity of 5-(methoxycarbonylsulfanyl)cysteine derivatives 9 (Scheme 21), and complications arising from their base lability and the risk of S N nnigration, this type of protection is not suitable for multistep peptide synthesis. The more recently proposed AT-methyl-AT-phenylcarbamoylsulfanyl (SMpc) derivative of cysteine (Scheme 21) is apparently less prone to sulfur to nitrogen shift. ... 

PMO postmenopausal osteoporosis SmPC summary of product characteristics... 

SmPC Recommendations Product Name Date and/or Number... 

Data sheets and SmPCs, prepared by individucil companies as required by statute, provide medicinal product information intended for health professionals. In general, the texts represent the particulars of the MA approved by the Licensing Authority. Participation in the Compendium is open to all companies supplying medicinal products intended for use under medical supervision. The Compendium is published approximately every 15 months and is available from Datapharm Publications. 

Module I is specific to the region in which the application is made (the EU in this case) and is, technically, not part of the CTD. It contains regional administrative information, a submission table of contents, the SmPC (i.e. the draft package insert), the patient information leaflet (PIL) (if any) and translation of the labeling into all relevant languages (in the case of a CP application this is now required in 22 languages). 

The RA in the RMS then evaluates the dossier and prepares an assessment report. All being well, the RMS then grants MA and agrees to the text of a final SmPC, and the labeling of the product. 

Following this initial approval, the RMS will then facilitate communication between the applicant and the CMS. The CMS may offer comments and suggestions for changing the SmPC. When there are opinions that diverge between the RMS and the CMS, and if efforts to compromise fail, arbitration may be requested by CMS, or even (rarely) by the applicant. All CMS must check the correct translation of the SmPC and labeling in their national language. The RMS refers an application to arbitration by the CHMP if needed. The RMS later handles all post-marketing issues, such as variations and renewals. 

The applicant then submits the dossier to the CMS. The application must be accompanied by a declaration that all the dossiers filed as part of the procedure are identical, including the SmPC. The SmPC is the fundamental document on which mutual recognition is based. The applicant also informs the EMEA that MRP is started, but a full dossier is only sent to the EMEA in case of arbitration. 

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