Licence holders

In September 2001, however, a news item in the British Medical Journal reported that further analyses confirmed the increase in rates of myocardial infarction and questioned whether this was an adverse reaction affecting the whole class of COX 2 drugs. The debate continued for the next 3 years with the main emphasis remaining on GI toxicity. A PEM study that included more than 15 000 patients made no mention of cardiovascular adverse events. However, a second paper compared rofecoxib and meloxicam with respect to thromboembolic events which showed that both, to a variable extent were associated with cardiovascular, cerebrovascular and peripheral venous pathology. A meta-analysis published recently in The Lancet suggests that Merck, the licence holder... 

They need assurance that the medicines they are offered fulfil these requirements and are supported by information that permits optimal use. The information about and the usage of medicines gets out of date, and there is an obligation on licence holders continually to review their licence with particular regard to safety. Marketing Authorisation Holders (MAH), i.e. pharmaceutical companies, can also change the efficacy claims to their licence, e.g. new indications, extension of age groups, or... 

Each MA has to be renewed every 5 years. This is best done by indicating the minor changes that have occurred (e.g., updating analytical methods). As in the EC Directives, this will also be the time to update the leaflets on post-marketing surveillance issues. The Medicines Commission will also evaluate the legal status of every MA at the 5-year renewal date. Major changes (e.g., inactive ingredients, licence holder) have to be submitted for approval separately before implementation. 

The establishment and licensing for pharmacy issues are specified by the 54th Act of 1994. In the medicine Act it is repeated that medicines are to be sold exclusively in pharmacies which may purchase them only from medicine wholesale licence holders. 

Liability (public health obligation) issues specify that MA holders must report to the MRA the cessation of marketing of any medicine when the last lot is delivered or at least three months before the manufacturing is terminated. Temporary marketing problems must cilso be reported. Wholesale and pharmacy licence holders may not deny purchase and selling of any medicines with valid Hungarian MA. Serious health injuries or deaths caused by a medicine in full compliance with... 

For purposes of validation and to avoid ciny double reporting, the Dutch reports should include the reporter s name and address. The Chief Inspectorate can request interim reports of ADRs. Physicians prescribing medicines to individual patients according to the declaration of awareness procedure outside clinical re-seetfch have to be informed by the licence holders of the product that they have to report the ADRs of their patients to the Healthcare Inspectorate. 

A copy of the Russian certificate of registration the pharmaceutical product for the licence-holder. 

A letter issued from the licence-holder concerning production of the pharmaceutical product under licence. 

Note Documents according to p. 6 are presented for licensed products documents according to p. 7 are presented for generics and also for licensed pharmaceutical products which are not registered in Russia by Licence-Holder. 

With the implementation of drug registration, certain companies that are not the product licence holder, may require one or more of the following licences ... 

Importers who do not hold product licences may apply for import licences to import registered medicineil products (See Appendix 4). The import licence will be issued to local importers who are authorised by the product licence holders to import licensed products on their behalf. This licence is valid for 3 years. 

Depending on the type of failure, batches of noncompliant products would have to be recalled from the market by the product licence holder in accordance to instructions from the Ministry of Health as stated in the following paragraphs. In severe failure, the product licence may be suspended or revoked by the Licensing Authority. 

The manufacturer or product licence holder would have to submit the following information to the Licensing Authority ... 

Please enclose document from the product owner authorising the applicant to be the product licence holder. ... 

Product licence holders are required to inform the Ministry of Health (MOH) of any changes to the details that were previously submitted in their product licence applications. Approval by MOH is required before the changes can be effected, with the exception of some minor amendments that require only notification to MOH. 

DRA-1 form - For inclusion of new indications or new dosage regime DRA-2 form - For change of product licence holder DRA-3 form - For other amendments... 

Letter issued by the product owner authorising the new product licence holder to hold the product licence in Singapore and withdrawing the authorisation previously given to the current product licence holder. 

Letter issued by the new product licence holder confirming that there are no changes to the product or other details submitted previously and that the product is currently registered in the country of manufacture. If there are other changes, the relevant DRA form and documents are also to be submitted in addition to DRA-2 form. 

Change of pharmacist employed by product licence holder... 

For Guidance, please refer to the Guide for Amendment of Product Licence , in particular item no. 5.11 of Annex 1. Sections A, B and D must be completed neatly by the licence holder. 

Section A - Details of Current and New Product Licence Holder... 

Advertising and promotion eire controlled, and certain requirements are laid down for packaging and labelling. Much effort is expended by licence holders and the regulatory authority in this area, and a very sophisticated level of regulatory practice heis developed. 

Under the Medicines Act, the licensing system for MAs, Manufacturer s, and Wholesale Dealer s Licences, and for Clinical Trial Certificates, allows the opportunity for an applicant or licence holder to appeal against an unfavourable recommendation or decision, right up to the High Court if necessary, although that has rarely happened. Nevertheless, appeals to the appropriate advisory committee such as the Committee on Safety of Medicines, and to the Medicines Commission, are commonplace in the process leading to grant of an MA. Appeals may also arise in connection with the suspension, revocation, or compulsory variation of MAs or certificates. Manufacturer s Licences and Wholesale Dealer s Licences are rarely subject of the need for such appeal action. 

Name and address of the licence holder, or trading style/address ... 

Abbreviated journal advertisements (with only the indication being given in the advertisement, bound into a publication and no larger than 420cm2) must contain the asterisked peirticu-lars and a statement that further information is available on request to the licence holder or in the Summary of Product Characteristics or data sheet. 

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