Pre-registration

Phase-in substances manufactured or imported in quantities of one tonne or more have to be pre-registered within a time period starting 12 months and ending 18 months after entry into force of REACH. The following information has to be submitted to the Agency for pre-registration  

The Agency intends to publish a list of all pre-registered substances on its website one month after the deadline of 18 months. This pre-registration phase will probably start in Summer 2008 and continue until the end of 2009 (source publication of the European Council in March 2006). All manufacturers or importers of such pre-registered phase-in substances in quantities of less than 1 tonne per year, as well as downstream users and third parties, have to submit to the Agency the same information as that required from the pre-registrants. 

The Agency intends to create a substance information exchange foram (SIEF). SIEF will allow the exchange of information on the study summaries between manufacturers and importers of the same substance in order to avoid duplication of studies and to harmonize classification and labelling. 

In general, sharing of data involving testing is required. This requirement is not limited to vertebrate animal tests. An increasing potential for conflict seems to be very likely. 

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The majority of validation data required for analytical methods supporting authorization purposes are common to those described for enforcement methods (see Section 4). However, some of the requirements such as minimum cost and commonly available equipment do not apply to methods supporting pre-registration studies (e.g., the use of GC/MS/MS technology). 

European Commission, Residues Guidance for Generating and Reporting Methods of Analysis in Support of Pre-registration Data Requirements for Annex II (Part A, Section 4) and Annex III (Part A, Section 5) of Directive 91/414, SANCO/3029/99 rev. 4, 11.07.00. European Commission, Bmssels (2000). 

Table 1 Analytical parameters of pre-registration and post-registration pesticide environmental fate studies...

The tests were undertaken by a sample of final-year pharmacy students following a five-year course, which included the pre-registration period. The percentage of students answering a question incorrectly is indicated for each test. Questions that were answered correctly by all students are not listed. 

Dosing strategies different from the administration schedules established in pre-registration trials (e.g. use of high doses of antipsychotics in treatment-resistant patients). 

Massai, R., et al. 1999. Pre-registration study on the safety and contraceptive efficacy of a progesterone-releasing vaginal ring on Chilean nursing women. Contraception 60 9. 

Leonard C, Fanning N, AttwoodJ, Buckley M. The effect of fatigue, sleep deprivation and onerous working hours on the physical and mental wellbeing of pre-registration house officers. Ir J Med Sci.1998 167 22-25. 

Each chapter contains five case studies, increasing in complexity from those we would expect first-year students to complete (Level 1) through to cases designed for fourth-year/pre-registration students (Level M). The chapters have been designed to follow approximately the British National Formulary chapters for ease of use. Case study scenarios include both community and hospital pharmacy situations as suited to the disease and pharmaceutical care provision. In a number of cases, abbreviations have been used and the editors have taken the decision not to provide a glossary of terms as we felt this to be another learning opportunity. 

The latter became evident when the pre-registration of chemicals under the EU REACH regulation came to include over 146,000 chemical substances, 20 times the number anticipated by the EU Commission (Dancet 2009). 

This is the case as long as pre-registration has taken place or is not required (Article 28). 

The data on which the estimated levels of exposure are based vary greatly. Some of the differences in these calculated exposure levels might be explained by the nse of different statistics, differences between pre-registration studies (UK model, German model and PHED) and surveillance (post-registration studies), but it is likely that some other (local) factors contribute substantially to the variance. 

Year Pre- clinical Phase 1 Phase II Phase III Pre- registration... 

Pharmaceutical evaluation document and Product pre-registration/ evaluation report (MCC Circular 2/97)... 

Part XIII - Payments in respect of pre-registration trainees... 

This part provides details of the payments to be made to pharmacy contractors who provide the pre-registration training experience needed by pharmacy graduates and certain undergraduates for admission to the Royal Pharmaceutical Society of Great Britain s Register of Pharmaceutical Chemists. 

Donald Cairns obtained a Bachelor of Science degree in pharmacy from the University of Strathclyde in 1980 and after a pre-registration year spent in hospital pharmacy, he returned to Strathclyde to undertake a PhD on the synthesis and properties of benzylimidazolines. Following a year as a postdoctoral research fellow in the department of pharmacy at Sunderland Polytechnic (now the University of Sunderland), Dr Cairns moved to Leicester Polytechnic (now De Montfort University) where he held a five-year lectureship in Pharmacy In 1992 Dr Cairns was appointed senior lecturer in medicinal chemistry in Sunderland School of Pharmacy and in 2003 moved to his present post of Associate Head of the School of Pharmacy at The Robert Gordon University in Aberdeen. In 2006, he was promoted to Professor of Pharmaceutical and Medicinal Chemistry at RGU. 

Questions on some topics have been poorly answered in the registration examination. These are usually highlighted in the Royal Pharmaceutical Society pre-registration bulletins and it may be useful to give these issues extra attention when revising. 

In assertion/reason questions in the pre-registration examination, discriminate carefully between keys A and B. A is the correct answer if the two statements are correct and can be linked with the word because. ... 

Much of the knowledge and all of the professional decision-making skills you need to answer questions in the registration examination should be acquired through your pre-registration training programme. 

The very large number of pre-registrations (ca. 2,750,000 on ca. 146,000 substances by more than 65,000 companies in 27 EU member states Table 2) has... 

A process which is in a state of control contributes to productivity and profitability by reducing waste increasing the yield of saleable product and reducing the cost of inspection and test activities. Moreover, appropriate validation studies will facilitate pre-registration audits and expedite product registration. Validation therefore makes good business sense. 

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