A rare neuroinflammatory disease characterized by the onset of ataxia, dysarthria and cerebral white matter changes that are triggered by viral infection. Episodic progressive neurodegeneration (manifesting with loss of motor and verbal skills, muscl

products containing any new substance to treat acquired immune deficiency syndrome (AIDS), cancer, neurodegenerative disorder, diabetes, or other immune disorders and viral diseases.

(Return tabled) Question No. 456 Ms. Kirsty Duncan: With respect to the current pandemic of new influenza A (H1N1): (a) what specific healthcare professional stakeholder groups have been consulted since the beginning of the H1N1 pandemic, what was the consultation process, and what concerns were raised; (b) what concerns from the consultation process have been addressed, what concerns are remaining, and by what date will they be addressed; (c) what, if any, additional funding was requested to address identified challenges; (d) do identified stakeholder groups report there are sufficient human resources and supplies to meet the need du ...[+++]ring a second wave of H1N1 and, if not, what are the identified gaps; (e) what, if any, additional education and training was requested by stakeholder groups; (f) what procedures are in place to ensure applicability, consistency and clarity of protocols to healthcare professional organizations, and do stakeholders report that they are receiving clear, concise, timely messaging; (g) what, if any, differences exist in how healthcare professionals will be protected among provinces and territories; (h) what specific agreements have been made in respect to assuring sufficient human resources during a second wave; (i) what, if any, differences exist between the national guidelines and those of the provinces and territories, with respect to antivirals, N-95 masks, vaccines, and other personal protective measures, and how should healthcare professionals address any discrepancies; (j) what are the known and suspected benefits and risks of the H1N1 vaccine; (k) what non-clinical and clinical trials have been or are being undertaken regarding the H1N1 vaccine, on what dates were they completed, and what are the outcomes of these trials; (l) what possible side effects, including rare events, might be expected with the H1N1 vaccine; (m) what are the possible legal risks associated with an H1N1 vaccination programme, and what efforts have ...

products containing any new substance to treat acquired immune deficiency syndrome (AIDS), cancer, neurodegenerative disorder, diabetes, or other immune disorders and viral diseases.

This procedure, now compulsory for high-technology medicinal products (gene therapy and associated cell therapies, xenogenic therapies) in order to maintain the high level of scientific evaluation and thus to preserve the confidence of medical professionals and patients, will also become compulsory for orphan medicinal products; for products containing a new active substance and indicated for the treatment acquired immune deficiency syndrome, cancer, neurodegenerative disorder or diabetes and, four years after the entry into force of the Regulation, also for the treatment of auto-immune diseases, immune dysfunctions and viral diseases.